BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT

    MDR report key: 1652529 · Received April 6, 2010

    Report

    Report Number
    2024800-2010-00001
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    January 24, 2009
    Report Date
    April 6, 2010
    Manufacturer
    GEN-PROBE INCORPORATED
    Product Code
    MDK
    PMA / PMN Number
    K974572
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE KIT LOT NUMBER (555368) OF THIS DEVICE WAS SUBJECT TO A RECALL DUE TO KITS POTENTIALLY CONTAINING EMPTY, OR PARTIALLY EMPTY, TUBES LABELED AS CONTAINING PROBE REAGENT. IF AN EMPTY OR PARTIALLY EMPTY TUBE IS USED FOR THE POSITIVE CONTROL, THIS COULD RESULT IN A DELAY IN CORRECTLY IDENTIFYING THE ISOLATE DUE TO AN INVALID TEST RUN. ALTERNATIVELY, IF A FILLED PROBE TUBE IS USED FOR THE POSITIVE CONTROL WHILE AN EMPTY OR PARTIALLY EMPTY PROBE TUBE IS USED FOR THE PATIENT TESTING, THIS COULD RESULT IN A FALSE NEGATIVE RESULT. ALL REAGENTS IN THE KIT WERE LABELED CORRECTLY. IT IS ESTIMATED THAT BETWEEN 1% AND 5% OF THE TUBES WERE DEFECTIVE IN THE IMPACTED LOTS. THERE ARE MULTIPLE POTENTIAL REASONS/CAUSES FOR THE INFANT CONTRACTING GROUP B (B) (6) IN (B) (6) 2009, ALTHOUGH, THE MATERNAL SPECIMEN TESTED NEGATIVE IN (B) (6) 2008. THE IVD TEST KIT (THE DEVICE) WAS USED UP AT THE TIME OF TESTING AND IS NOT AVAILABLE FOR FURTHER EVALUATION OR CONFIRMATION.

    Description of Event or Problem · 1

    THE DEVICE IS A GROUP B (B) (6) TEST THAT IS PRIMARILY USED FOR THE DETECTION OF GROUP B (B) (6) AT 36-38 WEEKS OF PREGNANCY. A MATERNAL SPECIMEN WAS TESTED IN (B) (6) 2008 WITH THIS DEVICE FROM A BATCH THAT WAS SUBSEQUENTLY RECALLED. THE TEST WAS NEGATIVE FOR GROUP B (B) (6). THE MOTHER DELIVERED ON (B) (6) 2009, THE CHILD PRESENTED AT AN EMERGENCY ROOM ON (B) (6) 2009, AND THE CHILD DIED FROM MASSIVE GROUP B STREP INFECTION ON (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT MDK GEN-PROBE INCORPORATED 555368

    Patients

    Seq Age Sex Outcome Treatment
    1 4 DA Death