BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3800488 · Received May 8, 2014

    Report

    Report Number
    1823260-2014-03297
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 15, 2014
    Report Date
    May 8, 2014
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVENT OCCURRED IN (B)(6). DEVICE WILL NOT BE RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED LOW BLOOD GLUCOSE SYMPTOMS WITH A RESULT OF 2.9 MMOL/L OBTAINED ON THE COMPACT PLUS SYSTEM. SHE SELF-TREATED WITH DEXTROSOL AND RE-TESTED ONE MINUTE LATER. THE RESULT WAS 3.1 MMOL/L SO THE CUSTOMER TOOK MORE DEXTROSOL. 5 MINUTES LATER THE CUSTOMER TESTED 24 MMOL/L, 12 MMOL/L, AND 17 MMOL/L ON THE COMPACT PLUS SYSTEM. THE CUSTOMER WENT TO THE HOSPITAL DUE TO THE ERRATIC RESULT. A PROFESSIONAL READING RETURNED AS 9.8 MMOL/L ABOUT 45 MINUTES AFTER THE LAST RESULT OBTAINED ON THE COMPACT PLUS SYSTEM. NO ADDITIONAL TREATMENT WAS NECESSARY. REQUESTED RETURN OF SUSPECT DEVICE HOWEVER THE TEST CASSETTE HAS BEEN DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277897 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 045 YR