BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3921640 · Received July 9, 2014

    Report

    Report Number
    2531779-2014-19356
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 03/06/2015 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX STARTS ON (B)(6) 2015. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA AND HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. NO ALARMS RELATED TO THE COMPLAINT IN CURRENT ALARM HISTORY. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. A DELIVERY ACCURACY TEST WAS PERFORMED; PUMP PASSED AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED RANGE. UNRELATED TO THE COMPLAINT, THE BATTERY COMPARTMENT IS CRACKED BELOW THE BUMPER PAD. 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 FOR EVALUATION. 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) BETWEEN 250 AND 400 MG/DL, WITH SYMPTOMS SUCH AS EXTREME DROWSINESS/DIFFICULTY WAKING UP/CONFUSION. THE REPORTER STATES THAT PUBERTY IS THE CAUSE OF THE BG EXCURSION AND THERE IS NO ALLEGATION OF PUMP MALFUNCTION. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPERGLYCEMIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400528 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Life Threatening