BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3832329 · Received May 27, 2014

    Report

    Report Number
    2531779-2014-14811
    Event Type
    Injury
    Date Received
    May 27, 2014
    Report Date
    May 9, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 06/24/2014 WITH THE FOLLOWING FINDINGS: NO DEFECT WAS FOUND. UNABLE TO DUPLICATE REPORTED COMPLAINT. THE LAST BASAL DELIVERY AND THE LAST BOLUS WERE ON (B)(4) 2014. NO ALARMS RELATED TO THE COMPLAINT NOTED IN THE ALARM HISTORY; ONLY TYPICAL USAGE OBSERVED. THE BASAL AND BOLUSES ADD UP APPROPRIATELY TO TOTAL THE TDD; SHOWING THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. ANIMAS HAS CONDUCTED A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS PUMP AND CONFIRMED THAT IT WAS OPERATING WITHIN REQUIRED SPECIFICATIONS AT THE TIME OF RELEASE.

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT THE PATIENT HAD A BLOOD GLUCOSE (BG) OF 515 MG/DL WITH LARGE KETONES, NAUSEA, AND ABDOMINAL PAIN/VOMITING. THE PATIENT IS TAKING ZYRTEC. CUSTOMER SUPPORT FOUND NO DELIVERY ISSUES WHEN TROUBLESHOOTING THE PUMP. THE REPORTER FEELS THAT THE BG EXCURSION IS DUE TO PUBERTY, BUT THE PUMP IS BEING REPLACED UPON REQUEST OF THE HEALTH CARE PROVIDER. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA, AND ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311243 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Life Threatening