BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3020348 · Received March 25, 2013

    Report

    Report Number
    1823260-2013-01823
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    February 21, 2013
    Report Date
    March 25, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 PERFORMA NANO SYSTEM.

    Description of Event or Problem · 1

    REPORTER STATED THAT CUSTOMER RECEIVED THE FOLLOWING RESULTS ON THE MOBILE SYSTEM WITHIN 1 MINUTE AND 3 MINUTES RESPECTIVELY: HI (RESULT OVER 600 MG/DL) AND 130 MG/DL LO (RESULT LESS THAN 10 MG/DL) AND AN APPROXIMATE RESULT BETWEEN 120 MG/DL AND 130 MG/DL REPORTER ALSO STATED THAT PATIENT RECEIVED THE FOLLOWING RESULTS, WITH TWO DIFFERENT METERS WITHIN 5 MINUTES: 44 MG/DL (MOBILE SYSTEM) AND 250 MG/DL (PERFORMA NANO SYSTEM). EACH SET OF READINGS WERE TAKEN AT DIFFERENT TIMES. 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
    121775 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278122

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR