BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC TRIAGE PANEL 25 TEST

    MDR report key: 1432839 · Received May 7, 2009

    Report

    Report Number
    2027969-2009-00303
    Event Type
    Malfunction
    Date Received
    May 7, 2009
    Date of Event
    March 23, 2009
    Report Date
    May 7, 2009
    Manufacturer
    BIOSITE INCORPORATED
    Product Code
    MMI
    PMA / PMN Number
    030286
    Removal / Correction Number
    NI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING OF RETURNED CUSTOMER DEVICES (W44467) AGAINST QC RETAINED DEVICES (W44467) WITH QCR CAL C, E, AND G FOR OBSERVATIONS FOR LOW RECOVERY OF CK-MB. PRODUCT SUPPORT OBSERVED LOW BIAS IN RECOVERY, RANGING FROM 62%-85%, FOR EACH ANALYTE AT EVERY LEVEL. MULTIPLE DATA POINTS WERE BELOW THE MFG 2SD RANGE FOR CKMB. LOW RECOVERY FOR EACH ANALYTE HAS BEEN DOCUMENTED WITH (B) (4). PRODUCT SUPPORT CONFIRMED THE LOW ANALYTE RECOVERY FOR DEVICE LOT W44467. PRODUCT SUPPORT OBSERVED 2 ERROR CODES ON CAL H INITIAL (E:256, SPOT 5 FAILED AND E:64, SPOT 3 FAILED). NO STANDARD OUTLIERS WERE OBSERVED FOR CKMB RECOVERY. PRODUCT SUPPORT OBSERVED ONE LOW DATA POINT ON CAL E THAT RECOVERED BELOW THE MFG 2SD RANGE. PRODUCT SUPPORT OBSERVED THE CV'S AND % RECOVERIES TO BE WITH IN THE MFG SPECS. ISSUE (B) (4) WAS OPENED IN ORDER TO REVIEW THE LOT FURTHER AND DETERMINE POSSIBLE FURTHER ACTION. CAPA (B) (4) HAS BEEN INITIATED AND A RECALL, (B) (4) HAS BEEN INITIATED FOR THE LOT IN QUESTION.

    Description of Event or Problem · 1

    TRIAGE CARDIAC DEVICE DEMONSTRATED LOW RECOVERY RESULTS FOR CKMB WHILE TESTING WITH CONTROLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC TRIAGE PANEL 25 TEST CARIAC MARKER TEST MMI BIOSITE INCORPORATED 97001HS W44467

    Patients

    Seq Age Sex Outcome Treatment
    1 NI