BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2111889 · Received June 2, 2011

    Report

    Report Number
    1823260-2011-02969
    Event Type
    Malfunction
    Date Received
    June 2, 2011
    Date of Event
    May 23, 2011
    Report Date
    July 12, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFORMATION INCLUDING WHAT IS REQUESTED IN THESE FIELDS. 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 AN EMPTY VIAL WAS RETURNED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DECLINED TO PROVIDE ANY FURTHER INFORMATION INCLUDING WHAT IS REQUESTED IN THESE FIELDS. IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF 359 MG/DL AND 122 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. NO 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 207295

    Patients

    Seq Age Sex Outcome Treatment
    1 CONTINUOUS INSULIN PUMP