BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 3852533 · Received June 5, 2014

    Report

    Report Number
    2531779-2014-16006
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 29, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 07/18/2014. DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 07/03/2014 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWED THAT THE LAST BOLUS AND THE LAST BASAL WERE DELIVERED ON 06/05/2014, AND THERE WERE NO ALARMS OUTSIDE THE RANGE OF NORMAL PATIENT USE. THE BASAL AND BOLUS TOTALS ADDED UP APPROPRIATELY TO THE TOTAL DAILY DOSE TOTALS SHOWING THAT THE THE PUMP WAS DELIVERING ACCURATELY UNTIL THE LAST DATE USED. THE PUMP SUCCESSFULLY PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATION AND DELIVERING ACCURATELY. PRODUCT ANALYSIS WAS UNABLE TO DUPLICATE THE REPORTED COMPLAINT. UNRELATED TO THE INITIAL COMPLAINT, THE DISPLAY SCREEN WAS OBSERVED TO HAVE A PINKISH CONTRAST. 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 ALLEGING A HYPERGLYCEMIC EVENT ASSOCIATED WITH ALLEGED INACCURATE DELIVERY FROM THE PUMP. THE REPORTER STATED THAT ON (B)(6) 2014, THE PATIENT¿S BLOOD GLUCOSE WAS 476 MG/DL WITH SYMPTOMS OF VOMITING, FEELING OF PINS AND NEEDLES IN THE CHEST/CHEST PAIN, RAPID, DEEP BREATHING / SHORTNESS OF BREATH, AND ABDOMINAL PAIN / VOMITING. IT WAS REPORTED THAT THE PATIENT REMAINED ON THE PUMP AND DID NOT RECEIVE ANY TREATMENT ABOVE AND BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. REPORTEDLY, THE PATIENT¿S HEALTHCARE PROVIDER HAD NOT ADJUSTED THE PUMP SETTINGS BEFORE OR AFTER THE EVENT. TROUBLESHOOTING DETERMINED THAT THE PUMP HAD BEEN DELIVERING THE BASAL RATE AS IT WAS PROGRAMMED, ALL BOLUSES WERE RECORDED AS PROGRAMMED, AND THAT THE DAILY DELIVERY TOTALS MATCHED ALL PROGRAMMED SETTINGS. THIS COMPLAINT IS BEING REPORTED FOR ALLEGED HYPERGLYCEMIA OF UNCLEAR CAUSE WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328817 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Life Threatening