1. Triage Meter Pro User Manual Instructions

RALS DEVICE INTERFACE MENU. RALS systems are interfaced to devices you use at the point-of-care every day from market share leaders in glucose, coagulation, blood gas/electrolytes and cardiac markers, and more. Triage ® BNP Test, Alere Triage Cardio2 Panel and Alere Triage Cardio3 Panel devices and the Alere Triage Meter to assist the end user in monitoring product performance. Reagents Alere Triage ® Total 3 Control 1 or Alere Triage Total 3 Control 2 EDTA human plasma containing preservatives, CK-MB, troponin I and B-type natriuretic peptide (BNP.

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ALERE SAN DIEGO, INC. TRIAGE METER PRO CARDIAC MARKER TEST Back to Search Results Model Number 52111 Device Problems Power Cord (497); Smoking (1585); Device Inoperable (1663) Patient Problem No Consequences Or Impact To Patient (2199) Event Date 02/11/2011 Event Type Malfunction Event Description Caller reports power cord to triage barcode scanner was visibly smoking and no longer works. No surges in electricity were observed on site. No explanations for cord damage were offered or source of ignition were found. No personnel were injured or hurt on site. A replacement barcode kit was sent to the customer. Part #52111 corresponds to the replacement barcode kit, which includes the barcode reader and all of its individual accessories. The part number for the triage meter pro is (b)(4). Manufacturer Narrative Investigation pending. Search Alerts/Recalls

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Triage Meter Pro User Manual Instructions

Type of Device CARDIAC MARKER TEST Manufacturer (Section D) ALERE SAN DIEGO, INC. san diego CA Manufacturer Contact carmen bergelin, manager 9975 summers ridge road san diego, CA 92121 8588052256 MDR Report Key 2047391 MDR Text Key 19272143 Report Number 2027969-2011-00476 Device Sequence Number 1 Product Code KHO Combination Product (Y/N) N Reporter Country Code US PMA/PMN Number K973547 Number of Events Reported 1 Summary Report (Y/N) N Report Source Manufacturer Source Type Other,Health Professional Reporter Occupation NOT APPLICABLE Type of Report Initial Report Date 03/10/2011 1 Device Was Involved in the Event 0 PatientS WERE Involved in the Event: Date FDA Received 03/10/2011 Is This An Adverse Event Report? No Is This A Product Problem Report? Yes Device Operator HEALTH PROFESSIONAL Device MODEL Number 52111 Was Device Available For Evaluation? No Is The Reporter A Health Professional? Yes Date Manufacturer Received 02/11/2011 Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer Is The Device Single Use? Yes Is this a Reprocessed and Reused Single-Use Device? No Type of Device Usage Unkown