BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 7135820 · Received December 20, 2017

    Report

    Report Number
    2531491-2017-00004
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 20, 2017
    Report Date
    December 20, 2017
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    PMA / PMN Number
    K132086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED METER AND TEST STRIPS TO MANUFACTURER. THE RETURNED METER AND STRIPS WERE TESTED WITH CONTROL AND CLINICAL SAMPLES AND ALL RESULTS WERE WITHIN MANUFACTURING SPECIFICATIONS. REVIEWED BATCH RECORDS AND NO ABNORMAL ISSUES WERE FOUND IN THE MANUFACTURING PROCESS, TECHNICAL TESTING, OR QUALITY CONTROL INSPECTION. MANUFACTURING WAS COMPLIANT WITH THE DEVICE MASTER RECORD. THE RANGE FOR EACH LEVEL OF CONTROL SOLUTION WAS PRINTED CORRECTLY ON THE LABEL. NO ABNORMAL ISSUES WERE REPRODUCED. TO DATE THERE HAVE BEEN 18 COMPLAINTS OF SIMILAR ISSUES DURING THE PAST 2 YEARS. BASED ON THE REPORTED QYT. OF CPS AND QYT. OF PRODUCT SOLD IN THE LAST 2 YEARS THE CALCULATED COMPLAINT RATE IS (B)(4)% WHICH IS LESS THAN (B)(4)% SO THE FREQUENCY IS IMPROBABLE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED FALSE HIGH READINGS ON HER ON CALL EXPRESS BLOOD GLUCOSE METER. A TEST REPORTED HER BLOOD GLUCOSE (BG) WAS 319 MG/DL ON THE ON CALL METER. SHE FELT THIS WAS TOO HIGH. SHE THEN WENT TO THE ER AND HER BG WAS 234 MG/DL. SHE TESTED AGAIN THE FOLLOWING MORNING AND HER BG WAS 207 MG/DL BUT SHE SAID HER FASTING IS USUALLY AROUND 150 MG/DL. SHE HAS BEEN USING THIS METER FOR 1 WEEK. WHEN SHE TESTED THE CONTROLS, THE RESULTS WERE ALL IN THE EXPECTED RANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915890 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM BLOOD GLUCOSE METER NBW ACON LABORATORIES, INC. OGM-181 1190226

    Patients

    Seq Age Sex Outcome Treatment
    1