BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 2970295 · Received February 20, 2013

    Report

    Report Number
    1823260-2013-01084
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 28, 2013
    Report Date
    March 21, 2013
    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 CANADA 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 IS FOR THE INFORM II SYSTEM 2. (B)(4).

    Description of Event or Problem · 1

    REPORTER STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS, WITHIN 2 MINUTES: 3.0 MMOL/L (INFORM II SYSTEM 1) AND 5.7 MMOL/L (INFORM II SYSTEM 2) NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73964 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 470531

    Patients

    Seq Age Sex Outcome Treatment
    1 086 YR FERROUS SULFATE - 3X'S A DAY| FRAGMIN| NIFEDIPINE - 1X A DAY| ACEBUTOLOL - 1X A DAY| TAMOXIFEN - 1X A DAY| DUCOSATE SODIUM - 2X'S A DAY| TORADOL - EVERY 6 HRS