BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCUPROBE GROUP B STREPTOCOCCUS CULTURE ID KIT

    MDR report key: 2429569 · Received January 26, 2012

    Report

    Report Number
    2024800-2012-00001
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    December 30, 2008
    Report Date
    January 26, 2012
    Manufacturer
    GEN-PROBE INCORPORATED
    Product Code
    MDK
    PMA / PMN Number
    K974572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE KIT LOT NUMBER ASSOCIATED WITH THIS EVENT HAS NOT BEEN CONFIRMED BY THE LAB THAT PERFORMED THE TESTING, ALTHOUGH THE REPORTER OF THE INCIDENT HAS INDICATED THIS MAY BE THE SAME LOT NUMBER (555368) THAT WAS SUBJECT TO A RECALL AS DESCRIBED BELOW. (B)(4) KIT LOT NUMBER 555368 WAS SUBJECT TO A RECALL ON (B)(6) 2008 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 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 USED TO TEST A SAMPLE FOR GROUP B STREP WERE DEFECTIVE FOR THE IMPACTED LOTS. THIS RECALL HAS BEEN CLOSED BY FDA. THERE ARE MULTIPLE POTENTIAL REASONS/CAUSES FOR THE INFANT CONTRACTING GROUP B STREP ALTHOUGH THE MATERNAL SPECIMEN TESTED NEGATIVE. SINCE THE IVD TEST KIT (THE DEVICE) WAS USED AT THE TIME OF TESTING TO PERFORM THE MATERNAL TEST, IT WAS NOT AVAILABLE FOR FURTHER EVALUATION OR CONFIRMATION. THE "METHOD" AND "RESULTS" EVALUATION CODES INDICATED ABOVE REFLECT THE RECALL INVESTIGATION ONLY. THE "CONCLUSIONS" CODE REFLECTS THE ADVERSE EVENT EVALUATION COMPLETED AT THIS TIME. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    GEN-PROBE RECEIVED A COMPLAINT RELATED TO A CLOSED CLASS I RECALL THAT OCCURRED ON (B)(6) 2008. THE DEVICE IS A GROUP B STREP TEST THAT IS PRIMARILY USED FOR THE DETECTION OF GROUP B STREPTOCOCCUS AT (B)(6) OF PREGNANCY. A MATERNAL SPECIMEN WAS TESTED ON OR ABOUT (B)(6) 2008 WITH THIS DEVICE. THE TEST WAS NEGATIVE FOR GROUP B STREP. THE MOTHER DELIVERED A BABY BOY ON (B)(6) 2008 VIA VAGINAL DELIVERY. ON (B)(6) 2008, THE BABY WAS ADMITTED TO THE HOSPITAL BECAUSE OF PERSISTENT LOW-GRADE FEVER AND DECREASED LEFT ARM MOVEMENT. THE LAWSUIT STATES HE WAS ULTIMATELY DIAGNOSED WITH OSTEOMYELITIS, AN ACUTE BONE INFECTION, MOST COMMONLY DUE TO GROUP B STREP. THE LAWSUIT STATES HE CONTINUES TO SUFFER FROM THE EFFECT OF THIS INFECTION. THE KIT LOT NUMBER ASSOCIATED WITH THIS EVENT HAS NOT BEEN CONFIRMED BY THE LAB THAT PERFORMED THE TESTING, ALTHOUGH THE REPORTER OF THE INCIDENT HAS INDICATED THIS MAY BE THE SAME LOT NUMBER THAT WAS SUBJECT TO A RECALL AS DESCRIBED ON THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 12 DA Hospitalization