BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT PLUS TEST DRUM

    MDR report key: 4632344 · Received March 25, 2015

    Report

    Report Number
    1823260-2015-02420
    Event Type
    Malfunction
    Date Received
    March 25, 2015
    Date of Event
    March 11, 2015
    Report Date
    June 23, 2015
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K113614
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE STRIPS HAD EXPIRED.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: 1. "LO" (<10 MG/DL), 12 MG/DL, 130 MG/DL, AND 176 MG/DL 2. "LO" (<10 MG/DL), 16 MG/DL, 32 MG/DL, AND 136 MG/DL READINGS OF "LO" WERE NOT DUPLICATED. SETS OF READINGS WERE TAKEN AT DIFFERENT TIMES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECTED DEVICE AND STRIPS AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200535 ACCU-CHEK ® COMPACT PLUS TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208092

    Patients

    Seq Age Sex Outcome Treatment
    1 072 YR VALSARTAN| PANTOPRAZOLE| NOVOLOG| SIMVASTATIN| GLYBURIDE| LANTUS| METFORMIN| PIOGLITAZONE