BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCU-CHEK ® COMPACT TEST DRUM

    MDR report key: 3162641 · Received June 11, 2013

    Report

    Report Number
    1823260-2013-03517
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    May 16, 2013
    Report Date
    July 19, 2013
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    LFR
    PMA / PMN Number
    K031755
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS UNKNOWN IF THE INITIAL REPORTER SENT REPORT TO THE FDA. (B)(6).

    Description of Event or Problem · 1

    CALLER STATES THAT THE FOLLOWING READINGS WERE OBTAINED ON A PATIENT, USING THE COMPACT PLUS SYSTEM COMPARED TO A PROFESSIONAL METER AND A LAB RESULT, WITHIN 10 MINUTES: LOW 30S-RANGE MG/DL (EMT PROFESSIONAL METER), 111 MG/DL (COMPACT PLUS), AND LOW 30S-RANGE MG/DL (LAB). THE PATIENT WAS GIVEN TREATMENT BASED UPON THE LAB VALUE (TREATMENT NOT PROVIDED). THERE WAS A DELAY OF AT LEAST 30 MINUTES FROM THE READING OF 111 MG/DL TO TREATMENT AT THE HOSPITAL. IT IS UNKNOWN WHICH OF THREE COMPACT PLUS METERS WAS USED IN THE COMPARISON. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. CALLER STATES THAT CONTROLS WERE NOT RUN ON THE COMPACT PLUS DEVICES WITHIN 24 HOURS OF THE INCIDENT. REQUESTED RETURN OF SUSPECT DEVICE AND STRIPS, AND REPLACEMENT WAS SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262924 ACCU-CHEK ® COMPACT TEST DRUM BLOOD GLUCOSE MONITORING TEST STRIPS LFR ROCHE DIAGNOSTICS NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R