BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2597169 · Received June 4, 2012

    Report

    Report Number
    1823260-2012-02973
    Event Type
    Malfunction
    Date Received
    June 4, 2012
    Date of Event
    May 11, 2012
    Report Date
    June 4, 2012
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 300-399 MG/DL, 270-279 MG/DL, 250-259 MG/DL AND 100-199 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER STATED THAT SHE ATE A NORMAL BREAKFAST AND TOOK HER NORMAL MORNING 40 UNITS OF HUMULIN. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT SHE NO LONGER HAS THE STRIPS, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 087 YR VITAMINS (TYPE UNKNOWN)| HUMULIN (TWICE DAILY)