BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3191382 · Received June 26, 2013

    Report

    Report Number
    1823260-2013-03885
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 17, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 AVIVA SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON 2 DIFFERENT METERS WITHIN 1 MINUTE: 142 MG/DL (MOBILE SYSTEM) AND 69 MG/DL (AVIVA SYSTEM). THE CUSTOMER HAD HYPOGLYCEMIC SYMPTOMS OF TREMBLING AND SWEATING AT THE TIME OF THE RESULTS. NO TREATMENT REPORTED. 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
    289944 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278218

    Patients

    Seq Age Sex Outcome Treatment
    1 063 YR