BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 1971644 · Received January 27, 2011

    Report

    Report Number
    1823260-2011-00457
    Event Type
    Malfunction
    Date Received
    January 27, 2011
    Date of Event
    January 15, 2011
    Report Date
    January 27, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED OBTAINING THE RESULTS OF LO (LESS THAN 10 MG/DL) AND 138 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE COMPACT PLUS SYSTEM. REPORTER ALLEGED THAT HE DRANK ORANGE JUICE AFTER HE OBTAINED THE LO RESULT. REPORTER STATED THAT HE TOOK HIS MEDICATION AS HE NORMALLY WOULD AFTER OBTAINING THE HIGHER RESULT. NO OTHER ACTIONS WERE REPORTED TAKEN OR TREATMENT RECEIVED. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE AFFECTED PRODUCT. REPORTER STATED THAT THE STRIPS WERE GONE, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    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
    1 055 YR NOVOLOG (SLIDING SCALE)| LIPITOR| GLYBURIDE| ASPIRIN| METFORMIN| LANTUS