BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3120330 · Received May 20, 2013

    Report

    Report Number
    1823260-2013-03053
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    April 21, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1. HI (GREATER THAN 600 MG/DL), 171 MG/DL, 552 MG/DL, AND 59 MG/DL (WITHIN 2 MINUTES) 2. 545 MG/DL AND 170 MG/DL (WITHIN 2 MINUTES) SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. WITH FIRST SET OF READINGS, CUSTOMER FELT HYPOGLYCEMIC, HAD SHAKES AND CHILLS. CUSTOMER SELF-TREATED WITH JUICE AND FELT BETTER. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222280 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 207347

    Patients

    Seq Age Sex Outcome Treatment
    1 055 YR METFORMIN| LANTUS| CRESTOR| LISINOPRIL| HUMALOG