BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 2820979 · Received November 6, 2012

    Report

    Report Number
    1823260-2012-05628
    Event Type
    Malfunction
    Date Received
    November 6, 2012
    Date of Event
    October 11, 2012
    Report Date
    December 17, 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

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES: LO (LESS THAN 10 MG/DL), LO (LESS THAN 10 MG/DL), AND 107 MG/DL. CUSTOMER USED ONE DRUM OF STRIPS WITH READINGS OF LO, AND ANOTHER DRUM OF STRIPS TO OBTAIN READING OF 107 MG/DL. CUSTOMER DID NOT PROVIDE THE LOT NUMBER OF EITHER DRUM OF STRIPS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS; HOWEVER, STRIPS FROM DRUMS HAVE BEEN DISCARDED. REPLACEMENT WAS SENT.

    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
    1 062 YR MULTI VITAMIN| FISH OIL| METFORMIN| GLUCOSAMINE