BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    MDR report key: 2760093 · Received September 26, 2012

    Report

    Report Number
    1823260-2012-04819
    Event Type
    Malfunction
    Date Received
    September 26, 2012
    Date of Event
    August 27, 2012
    Report Date
    January 10, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    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 STATED THAT PATIENT OBTAINED BLOOD GLUCOSE RESULTS OF 6.3 MMOL/L AND 3.1 MMOL/L, WITHIN 1 MINUTE, ON THE AVIVA NANO SYSTEM. AT THE TIME THE RESULTS WERE OBTAINED, PATIENT REPORTEDLY FELT HYPOGLYCEMIC. REPORT NOTES THAT EMERGENCY SERVICES WERE SUMMONED AND, AT AN UNSPECIFIED TIME, PATIENT'S BLOOD GLUCOSE MEASURED 3.X MMOL/L (EXACT VALUE WAS NOT REPORTED). NO TREATMENT WAS REPORTED AND NO ADVERSE EVENT OCCURRED. THE MANUFACTURER REQUESTED THE RETURN OF THE SUSPECT PRODUCT FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK ® AVIVA PLUS TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 491042

    Patients

    Seq Age Sex Outcome Treatment
    1 070 YR LANTUS| HUMALOG