BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1657948 · Received April 13, 2010

    Report

    Report Number
    1823260-2010-02208
    Event Type
    Malfunction
    Date Received
    April 13, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 15, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    A PATIENT WAS ADMITTED TO THE ER WITH A SUSPECTED CARDIAC EVENT AND TROPONIN T TESTS WERE RUN SEVERAL TIMES WITH A STABLE RESULT AROUND 50 NG/L. THE NEXT DAY, (B) (6) 2010, THE TROPONIN T RESULT FROM A NEW SAMPLE WAS 393 NG/L AND WAS REPORTED TO THE WARD. THE NEXT DAY, (B) (6) 2010, THE WARD CALLED BACK TO THE LAB AND QUESTIONED THE RESULT. A NEW SAMPLE WAS DRAWN AND ANALYZED WITH A RESULT AROUND 50 NG/L. THE SAMPLE WHICH INITIALLY RECOVERED 393 NG/L WAS ANALYZED AGAIN WITH A NEW LOT NUMBER OF REAGENT AND RECOVERED AROUND 50 NG/L. THE PATIENT WAS GIVEN 500 IU FRAGMIN AS A CONSEQUENCE OF THE FALSE POSITIVE RESULT. NO OTHER TREATMENT OR MEDICATION WAS CHANGED AND THE PATIENT DID NOT COME TO ANY HARM. THE TROPONIN T REAGENT LOT NUMBER AT THE TIE OF THE INITIAL RESULT WAS 153401. THE REAGENT LOT AT THE TIME OF THE REPEAT RESULT WAS 154101.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: LO (LESS THAN 10 MG/DL), LO (LESS THAN 10 MG/DL), AND 325 MG/DL. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20720742

    Patients

    Seq Age Sex Outcome Treatment
    1 081 YR