BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK PERFORMA TEST STRIPS

    MDR report key: 2152136 · Received July 7, 2011

    Report

    Report Number
    1823260-2011-03639
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 15, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). ON (B)(6) 2011, INFORMATION WAS PROVIDED THAT THE BECOME AWARE DATE WAS (B)(6) 2011 (NOT (B)(6) 2011 AS ORIGINALLY NOTED ON EMDR). CODES ALTERED TO REFLECT RETENTION TESTING RESULTS.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA SYSTEM WITHIN 10 MINUTES: 16.9 MMOL/L, 0.9 MMOL/L, AND 2.5 MMOL/L, 2.4 MMOL/L AND 4.9 MMOL/L, 1.6 MMOL/L AND 7.8 MMOL/L THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE, HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 013 YR UNKNOWN INSULIN| ANIMAS INSULIN PUMP