BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 3030964 · Received April 2, 2013

    Report

    Report Number
    1823260-2013-01981
    Event Type
    Malfunction
    Date Received
    April 2, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 11, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278213, EXPIRATION DATE 06/30/2014). REFERENCE MEDWATCH REPORT WITH (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA NANO SYSTEM. ON (B)(4) 2013, CLARIFICATION WAS PROVIDED THAT THE CONTACT WITH THE CUSTOMER FIRST OCCURRED ON (B)(6) 2103, AND FURTHER DETAILED INFORMATION WAS RECEIVED ON (B)(4) 2013.

    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 REPORT IS FOR THE SUSPECT DEVICE USED IN THE MOBILE SYSTEM (LOT NUMBER 278213, EXPIRATION DATE 06/30/2014). REFERENCE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6) FOR THE SUSPECT DEVICE USED IN THE AVIVA NANO SYSTEM.

    Description of Event or Problem · 1

    CUSTOMER RECEIVED RESULT OF 159 MG/DL ON THE MOBILE SYSTEM AND A RESULT OF 59 MG/DL ON THE AVIVA NANO SYSTEM WITHIN 10 MINUTES. LOW BLOOD GLUCOSE SYMPTOMS WERE REPORTED WITH THESE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135280 ACCU-CHEK ® MOBILE TEST STRIPS BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA 278213

    Patients

    Seq Age Sex Outcome Treatment
    1 009 YR