BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 4617820 · Received March 19, 2015

    Report

    Report Number
    1823260-2015-02207
    Event Type
    Malfunction
    Date Received
    March 19, 2015
    Date of Event
    December 15, 2014
    Report Date
    June 8, 2015
    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. (B)(4).

    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. REFERENCE THE FOLLOWING MEDWATCHES WITH PATIENT IDENTIFIERS FOR THE FOLLOWING SYSTEMS: (B)(6) - COMPACT PLUS SYSTEM 1, SERIAL NUMBER - (B)(4); (B)(6) - MOBILE SYSTEM 2, SERIAL NUMBER - (B)(4). CORRECTION: CORRECT LOT NUMBER IS 2081094 AND CORRECT EXPIRATION DATE IS 12/31/2015. CORRECT MANUFACTURE DATE IS 06/30/2014.

    Description of Event or Problem · 1

    CALLER REPORTED OBTAINING THE FOLLOWING BLOOD GLUCOSE VALUES FROM HIS COMPACT PLUS SYSTEM (SYSTEM 1) AND HIS MOBILE SYSTEM (SYSTEM 2): 5.7 MMOL/L OR 6.2 MMOL/L ON COMPACT PLUS (SYSTEM 1) COMPARED TO 2.8 OR 3.1 MMOL/L ON MOBILE (SYSTEM 2). CALLER ALSO REPORTED RECEIVING 3.5 MMOL/L ON THE MOBILE SYSTEM (SYSTEM 2) AND 6.0 MMOL/L ON COMPACT PLUS SYSTEM (SYSTEM 1). NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF THE ALLEGED DEVICE FOR EVALUATION AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    186233 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 20810941

    Patients

    Seq Age Sex Outcome Treatment
    1 076 YR