BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 2854807 · Received December 3, 2012

    Report

    Report Number
    1823260-2012-06071
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 5, 2012
    Report Date
    December 18, 2012
    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.

    Description of Event or Problem · 1

    CALLER REPORTED FEELING WEAK WITH A MOBILE SYSTEM BLOOD GLUCOSE RESULT OF 3.4 AT 01:36AM, WAS ABLE TO SELF-TREAT WITH 2 GLASSES OF ORANGE JUICE AND A PEANUT BUTTER SANDWICH. SEVERAL ADDITIONAL RESULTS WERE REPORTED: 01:36AM: BG 3.4 MMOL/L, 01:42AM: BG 3.3 MMOL/L, 01:45AM: BG HI , WHICH ON THE SYSTEM INDICATES A RESULT OF OR HIGHER THAN 33.3MMOL/L), 01:46AM: BG 4.1 MMOL/L, 01:53AM: BG 5.6 MMOL/L, 02:00AM: BG 32.0 MMOL/L, 02:02AM: BG 22.0 MMOL/L, 02:05AM: BG 16.0 MMOL/L, 02:10AM: BG 6.9 MMOL/L. NO ADVERSE EVENT REPORTED. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 27815941

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR SYMBICORT PRN| ZOCORT - 20MG ORAL, ONCE A DAY| FOSINOPRIL - 1XDAY| METFORMIN - 500MG 2 TABS, TWICE A DAY| LANTUS - 3UNITS, AT BEDTIME| NOVORAPID - 10 UNITS, BEFORE LUNCHTIME| NORVASC - 10MG PO ORAL, ONCE A DAY| DIOVAN - 160/25 PO ORAL, ONCE A DAY| SYNTHROID - 175MG ORAL, ONCE A DAY