BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 1960976 · Received January 14, 2011

    Report

    Report Number
    1823260-2011-00245
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 14, 2010
    Report Date
    April 14, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    CUSTOMER REPORTEDLY RECEIVED THE FOLLOWING RESULTS ON THE PERFORMA COMBO SYSTEM WITHIN 10 MINUTES: 1.2 MMOL/L AND 4.8 MMOL/L; HI (GREATER THEN 33.3 MMOL/L) AND 9.7 MMOL/L; 1.7 MMOL/L AND 6.7 MMOL/L; 1.7 MMOL/L AND 6.0 MMOL/L; 1.5 MMOL/L AND 3.1 MMOL/L; 14.0 MMOL/L AND 6.8 MMOL/L; 5.3 MMOL/L AND 24.1 MMOL/L; 1.3 MMOL/L AND 8.0 MMOL/L; 1.9 MMOL/L AND 7.5 MMOL/L; 1.8 MMOL/L AND 6.3 MMOL/L; LO (LESS THEN 0.6 MMOL/L) AND 7.1 MMOL/L; 1.4 MMOL/L AND 3.4 MMOL/L; 0.9 MMOL/L, 11.5 MMOL/L, AND 13.3 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 AND 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 320392

    Patients

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