BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE COMPACT STRIPS

    MDR report key: 2170498 · Received July 21, 2011

    Report

    Report Number
    1823260-2011-03871
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 1, 2011
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE RECEIVED IN A CONDITION WHICH MADE ANALYSIS IMPOSSIBLE. UNABLE TO TEST BECAUSE AN EMPTY VIAL WAS RETURNED.

    Description of Event or Problem · 1

    CALLER REPORTED COMPACT PLUS BLOOD GLUCOSE RESULTS: 162 MG/DL, 159 MG/DL 218 MG/DL 187 MG/DL 199 MG/DL 381 MG/DL 272 MG/DL 292 MG/DL 379 MG/DL 474 MG/DL 600 MG/DL 442 MG/DL ALL RESULTS WERE WITHIN 15 MINUTES. REPORTED NO ADVERSE EVENT. A REQUEST WAS MADE FOR THE RETURN OF THE METER AND STRIPS, REPLACEMENT SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® MOBILE COMPACT STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 208000

    Patients

    Seq Age Sex Outcome Treatment
    1 067 YR "DIANBEN 850"| LOBIVON 5 MG/DL