BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® MOBILE TEST STRIPS

    MDR report key: 1891162 · Received November 4, 2010

    Report

    Report Number
    1823260-2010-06574
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    September 15, 2010
    Report Date
    November 4, 2010
    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
    NO
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(4). CALLER DID NOT PROVIDE PRODUCT INFORMATION FOR THE COMPACT PLUS SYSTEM. WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED TAKING 6 UNITS OF NOVORAPID VIA INSULIN PUMP BASED ON RESULT OF 23 MMOL/L OBTAINED ON THE MOBILE SYSTEM. FIVE MINUTES LATER CUSTOMER TESTED 12 MMOL/L ON THE MOBILE SYSTEM AND 11 MMOL/L ON A COMPACT PLUS SYSTEM. APPROXIMATELY 30 MINUTES LATER CUSTOMER "FELT BAD" AND TESTED 2.9 MMOL/L (UNKNOWN WHICH SYSTEM PRODUCED THIS RESULT). CUSTOMER'S MOTHER TREATED HER WITH SUGAR AND LOW BLOOD GLUCOSE SYMPTOMS IMPROVED. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER CUSTOMER NO LONGER HAS THE TEST 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 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 010 YR Other MEDTRONIC INSULIN PUMP| NOVORAPID