BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3163309 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03542
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 14, 2013
    Report Date
    June 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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.

    Description of Event or Problem · 1

    REPORTER ALLEGES RESULTS ARE HIGH ON DAUGHTER'S MOBILE SYSTEM AND DOES NOT TRUST THE METER ANY MORE. FOLLOWING TESTS WERE PERFORMED ON (B)(6) 2013: 378 MG/DL (08:19) 241 MG/DL (10:11) 100 MG/DL (12:00) 97 MG/DL (14:00) NO SYMPTOMS OR TREATMENT REPORTED DURING THESE TESTS. AT 16:50, THE METER DISPLAYED HI (RESULT OVER 600 MG/DL) "SEVERAL TIMES" AND THE CHILD FAINTED. THE CUSTOMER'S MOTHER GAVE HER UNSPECIFIED AMOUNTS OF HONEY, BREAD AND UNSPECIFIED INSULIN. AFTER ABOUT 20 MINUTES, CUSTOMER WAS "REACTIVE." THE TEST CASSETTE WAS CHANGED AT THIS TIME AND THE FOLLOWING RESULTS WERE OBTAINED AFTER THE INCIDENT: 91 MG/DL (17:08) 84 MG/DL (18:38H) 117 MG/DL (19:24H) 208 MG/DL (21:31H) 210 MG/DL (23:34H) AT THE SAME TIME 108 MG/DL ON A COMPETITOR DEVICE; 191 MG/DL (05:45H) NO SYMPTOMS OR TREATMENT REPORTED DURING THESE RESULTS. CUSTOMER HAS RECOVERED FULLY AND IS CURRENTLY FINE. THE MANUFACTURER REQUESTED RETURN OF SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263937 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278190

    Patients

    Seq Age Sex Outcome Treatment
    1 012 YR Required Intervention UNSPECIFIED INSULIN