BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMFORT CURVE TEST STRIPS

    MDR report key: 1904553 · Received November 22, 2010

    Report

    Report Number
    1823260-2010-06921
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    November 8, 2010
    Report Date
    December 1, 2010
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K010362
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CALLER REPORTED BLOOD GLUCOSE RESULTS OF 311 MG/DL ON ADVANTAGE SYSTEM 1, 119 MG/DL ON ADVANTAGE SYSTEM 2 WITHIN 10 MINUTES. REPORTED NO ADVERSE EVENT RELATIVE TO DISCREPANCY. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Description of Event or Problem · 1

    THE USER RECEIVED A QUESTIONABLE INTACT HUMAN CHORIONIC GONADOTROPIN + SS-SUBUNIT (HCG) RESULT FOR ONE PATIENT SAMPLE. ALL RESULTS ARE IN MIU/ML. THE INITIAL RESULT WAS 0.1 WITH A DATA FLAG AND WAS REPORTED OUTSIDE THE LABORATORY. THE DOCTOR CALLED AND QUESTIONED THE RESULT. ON (B)(6) 2010, THE LABORATORY REPEATED TESTING ON THE ORIGINAL ANALYZER AND THE RESULTS WERE 5176 AND 5501. THE SAMPLE WAS REPEATED ON A DIFFERENT E MODULE IN THE LABORATORY AND THE RESULTS WERE 5654, 8354, 7204 AND 6251. THE USER CONSIDERED THE RESULTS FROM SECOND E MODULE TO BE CORRECT. THE USER DID NOT THINK THERE WAS ANY AFFECT TO THE PATIENT SINCE SHE WAS PREGNANT AND THE PROVIDER CALLED TO QUESTION THE RESULT. THE HCG REAGENT LOT NUMBER WAS 15851502. THE FIELD SERVICE REPRESENTATIVE DETERMINED THERE WAS NO SAMPLE DISPENSED. HE CHECKED AND ADJUSTED THE SAMPLE PROBE AND CLOT DETECTION. TO VERIFY THE ANALYZER OPERATION, HE RAN AND OBSERVED SAMPLING AND CELL CHECKS. THE USER RAN CALIBRATION, QUALITY CONTROL AND SAMPLES. ALL RESULTS WERE WITHIN RANGE AND THE SAMPLES REPEATED CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® COMFORT CURVE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS 551403

    Patients

    Seq Age Sex Outcome Treatment
    1 083 YR LISINOPRIL 1XDAY| GLIPIZIDE 2XDAY| SIMVASTATIN 2XDAY| ATROVENT INHALER