BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2171735 · Received July 22, 2011

    Report

    Report Number
    1823260-2011-03903
    Event Type
    Malfunction
    Date Received
    July 22, 2011
    Date of Event
    June 17, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 485 MG/DL AND 178 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER STATED THAT AFTER THE READINGS, SHE WITHHELD TAKING APIDRA AS SHE NORMALLY WOULD BEFORE MEALS AND THEN SHE ATE BREAKFAST. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT.

    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 207266

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR LANTUS| APIDRA| THYROID MEDICATION| BUMEX