BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3840455 · Received May 30, 2014

    Report

    Report Number
    1823260-2014-03854
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 5, 2014
    Report Date
    July 9, 2014
    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 (B)(6). WHILE THIS PRODUCT IS NOT SOLD IN THE UNITED STATES, IT IS LIKE OR SIMILAR TO A PRODUCT MARKETED IN THE UNITED STATES. THIS MEDWATCH REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278229, EXPIRATION DATE 09/30/2014). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FEELING UNWELL AND WAS SWEATY. HE TESTED 19.8 MMOL/L ON THE MOBILE SYSTEM AT 00:17; AT 00:20 HE INJECTED "TORONTO" INSULIN AND TESTED 3.7 MMOL/L ON THE COMPACT PLUS SYSTEM AT 00:30. THE CUSTOMER RECEIVED RESULTS OF 4.0 MMOL/L (00:33) AND 10.0 MMOL/L (00:34) ON THE MOBILE SYSTEM. APPROXIMATELY 20 MINUTES LATER HE RECEIVED RESULTS OF HI (GREATER THAN 33.3 MMOL/L) AND 7.4 MMOL/L WITHIN 10 MINUTES OF EACH OTHER ON THE MOBILE SYSTEM. NO ADVERSE EVENT RELATED TO THE DEVICE WAS REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318206 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278229

    Patients

    Seq Age Sex Outcome Treatment
    1 056 YR "TORONTO" INSULIN