BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM

    MDR report key: 9477508 · Received December 16, 2019

    Report

    Report Number
    2531491-2019-00010
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ACON LABORATORIES, INC.
    Product Code
    NBW
    UDI-DI
    00682607000074
    PMA / PMN Number
    K132086
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS FOLLOW-UP REPORT, THE FOLLOWING INFORMATION IS DIFFERENT FROM THE INITIAL REPORT AS THE INTERNAL INVESTIGATION WAS COMPLETED. B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. G7: TYPE OF REPORT - FOLLOW-UP. H2: ADDITIONAL INFORMATION AND DEVICE EVALUATION. H3: DEVICE EVALUATED BY MANUFACTURER. H6: EVENT PROBLEM AND EVALUATION CODES- RESULT CODE. H6: EVENT PROBLEM AND EVALUATION CODES- CONCLUSION CODE.

    Description of Event or Problem · 0

    THE PRODUCT WAS NOT RETURNED BY THE CUSTOMER FOR EVALUATION. IN-HOUSE TESTING WAS PERFORMED WITH RETENTION STRIPS AND LABORATORY METER. THE FINAL INVESTIGATION REVEALED THAT DURING CONTROL SOLUTION TESTING, ALL RESULTS FELL WITHIN THE CONTROL RANGE. THE BLOOD GLUCOSE LEVELS TESTING WAS ALSO PERFORMED WITH RETENTION STRIPS AND ALL RESULTS MET THE ACCEPTANCE CRITERIA. THE BATCH RECORDS WERE REVIEWED, AND NO ABNORMAL ISSUES WERE OBSERVED IN MANUFACTURING PROCESS, TECHNICAL TESTING AND QUALITY CONTROL INSPECTION. THE RANGE OF EACH LEVEL OF THE CONTROL SOLUTION WAS FOUND TO BE PRINTED ON THE LABEL. THE MANUFACTURING PROCESS COMPLIED WITH THE DMR. THE REPORTED ISSUE OF INACCURATE READINGS ON THE GLUCOSE METER COULD NOT BE CONFIRMED, AND NO ROOT CAUSE WAS IDENTIFIED. NO ANOMALIES WERE FOUND TO INDICATE A SYSTEMIC ISSUE THAT WOULD ANTICIPATE INJURY OR ADVERSELY IMPACT THE PATIENT'S HEALTH.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED ON 01/01/19 THAT SHE STARTED TESTING WITH HER NEW GLUCOSE METER AND STRIPS. SHE WAS FEELING DIZZY SO SHE CHECKED HER BLOOD SUGAR. SHE GOT A READING OF 96 BUT SHE FELT LIKE HER GLUCOSE READING WAS MUCH LOWER BASED ON HER SYMPTOMS (DIZZY). SHE MENTIONED THAT SHE WENT TO HER DOCTOR AND THEY TESTED ON THE ON CALL EXPRESS (OCX) METER AND GOT A READING OF 96 BUT WHEN SHE TESTED ON HER DOCTOR'S METER IT GAVE A READING OF 60. REPORTEDLY, SHE TESTED THE CONTROLS AND THEY TESTED IN RANGE. SHE WOULD LIKE THE METER REPLACED BECAUSE SHE DOESN'T BELIEVE IT'S READING CORRECT. AS PER THE CUSTOMER, STRIPS HAVE BEEN OPENED LESS THAN A WEEK. THEY HAVE NOT BEEN EXPOSED TO HEAT OR HUMIDITY. SHE CONFIRMED THAT SHE TESTED PROPERLY. THE PRODUCT HAS NOT BEEN RETURNED BY THE CUSTOMER FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1270536 ON CALL EXPRESS BLOOD GLUCOSE MONITORING SYSTEM GLUCOSE TEST SYSTEM NBW ACON LABORATORIES, INC. OGM-181 GM190619 00682607000074

    Patients

    Seq Age Sex Outcome Treatment
    1