BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1783863 · Received August 4, 2010

    Report

    Report Number
    1823260-2010-04633
    Event Type
    Malfunction
    Date Received
    August 4, 2010
    Date of Event
    April 30, 2010
    Report Date
    August 4, 2010
    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). WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA COMBO SYSTEM WITHIN 10 MINUTES: 3.1 MMOL/L AND 7.0 MMOL/L;) 2.8 MMOL/L, AND 4.9 MMOL/L; 17.8 MMOL/L AND 8.8 MMOL/L; 29.2 MMOL/L AND 4.0 MMOL/L; 3.5 MMOL/L, 3.6 MMOL/L, 3.6 MMOL/L, AND 6.8 MMOL/L; 3.8 MMOL/L AND 10.3 MMOL/L; 5.5 MMOL/L AND 3.2 MMOL/L; 6.0 MMOL/L AND 2.9 MMOL/L; 5.8 MMOL/L AND 3.4 MMOL/L; 5.1 MMOL/L AND 3.2 MMOL/L; 16.3 MMOL/L AND 8.0 MMOL/L; 26.5 MMOL/L AND 5.7 MMOL/L; 17.3 MMOL/L AND 5.7 MMOL/L; 2.8 MMOL/L AND 8.0 MMOL/L; 3.3 MMOL/L AND 5.4 MMOL/L. THE COMPARISONS WERE PERFORMED ON DIFFERENT DATES. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST STRIPS; REPLACEMENT WAS SENT.

    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 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 007 YR UNK INSULIN| SPIRIT INSULIN PUMP