BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® PERFORMA TEST STRIPS

    MDR report key: 3165691 · Received June 12, 2013

    Report

    Report Number
    1823260-2013-03557
    Event Type
    Malfunction
    Date Received
    June 12, 2013
    Date of Event
    May 16, 2013
    Report Date
    June 12, 2013
    Manufacturer
    NA
    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. THIS MEDWATCH IS FOR THE INFORM SYSTEM 2. (B)(6).

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 9 MINUTES: 17.4 MMOL/L AT 11:32 AND 12.2 MMOL/L AT 11:34 (INFORM SYSTEM 1) AND 5.2 MMOL/L AT 11:41 AND 11.9 MMOL/L AT 11:46 (INFORM SYSTEM 2). NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION; HOWEVER, THE TEST STRIPS ARE NOT AVAILABLE ANY LONGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265322 ACCU-CHEK ® PERFORMA TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR NA NA 551928

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR VITAMIN D - 1X A DAY| SEROQUEL - 1X A DAY| MULITVITAMIN - 1X A DAY| MAGNESIUM OXIDE - 2X'S A DAY| LANTUS - 1X A DAY| CELEXA - 1X A DAY| LIPITOR - 1X A DAY| HUMALOG - 3X'S A DAY| COUMADIN - 1X A DAY| NICODERM - 1X A DAY| SPIRIVA - 1X A DAY| CARDIAZEM - 1X A DAY| VITAMIN B1 - 1X A DAY