BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2211161 · Received August 15, 2011

    Report

    Report Number
    1823260-2011-04338
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    REPORTER ALLEGED THAT ON (B)(6) 2011, HE OBTAINED THE RESULTS OF 342 MG/DL AND 110 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE MOBILE SYSTEM. REPORTER ALSO ALLEGED THAT ON (B)(6) 2011, HE OBTAINED THE RESULTS OF 251 MG/DL AND 96 MG/DL BACK TO BACK WITHIN 10 MINUTES ON THE SAME MOBILE SYSTEM. NO 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 UNAVAILABLE AND USED UP COMPLETELY, SO NO PRODUCT WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 060 YR