BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2132433 · Received June 17, 2011

    Report

    Report Number
    1823260-2011-03312
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 17, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN CANADA. MEDWATCH WITH IDENTIFIER (B)(6) IS FOR MOBILE SYSTEM, MEDWATCH WITH IDENTIFIER (B)(6) IS FOR COMPACT PLUS SYSTEM . STRIPS NOT AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    CALLER REPORTED SYMPTOMS OF HYPOGLYCEMIA, THEN HAD MOBILE SYSTEM BLOOD GLUCOSE RESULTS OF 5.8 MMOL/L, 7.9 MMOL/L, AND "IN THE 6'S" MMOL/L, COMPACT PLUS SYSTEM RESULT OF 3.2 MMOL/L WITHIN 10 MINUTES. CUSTOMER TREATED THE HYPOGLYCEMIA. REPORTED NO ADVERSE EVENT. MOBILE STRIPS NOT AVAILABLE FOR RETURN, REPLACEMENT SENT.

    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
    1 065 YR INSULIN PUMP