BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3912897 · Received July 3, 2014

    Report

    Report Number
    1823260-2014-04889
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    May 25, 2014
    Report Date
    August 18, 2014
    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 (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 MOBILE SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE COMPACT PLUS SYSTEM. MANUFACTURER WAS UNABLE TO COMPLETE USE TESTING BECAUSE LAST AVAILABLE TEST ON RETURNED CASSETTE WAS ERRANTLY CONSUMED BY INVESTIGATION UNIT.

    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 MOBILE SYSTEM. REFERENCE MEDWATCH WITH PATIENT IDENTIFIER (B)(6) FOR THE COMPACT PLUS SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 1 MINUTE: 1. 27.4 MMOL/L (MOBILE SYSTEM) AND 6.5 MMOL/L (COMPACT PLUS SYSTEM) 2. HI (RESULT >33.3 MMOL/L), 32.6 MMOL/L (MOBILE SYSTEM) AND 10.5 MMOL/L (COMPACT PLUS SYSTEM) SETS OF READINGS WERE TAKEN ON DIFFERENT DAYS. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT DUE TO THE DEVICE REPORTED. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391326 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 27823144

    Patients

    Seq Age Sex Outcome Treatment
    1 065 YR NOVORAPID