BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6131335 · Received November 29, 2016

    Report

    Report Number
    2531779-2016-32348
    Event Type
    Injury
    Date Received
    November 29, 2016
    Report Date
    November 3, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12/5/2016. ANIMAS HAS RECEIVED ADDITIONAL INFORMATION THAT INDICATES THE PRIMARY PRODUCT THAT IS THE SUBJECT OF THIS COMPLAINT IS NOT, IN FACT, THE INSULIN PUMP BUT IS THE INFUSION SET. THE ANIMAS INSULIN PUMP HAS BEEN DETERMINED TO HAVE BEEN A FACTOR IN THIS COMPLAINT. ANIMAS WILL FORWARD THIS COMPLAINT TO THE APPROPRIATE DEVICE MANUFACTURER.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON 11/3/2016 ALLEGING THE PATIENT EXPERIENCED HYPERGLYCEMIA ON (B)(6) 2016 WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASUREMENT OF 396, 260, 245 AND 279 MG/DL WITH THE ASSOCIATED SYMPTOM OF ABDOMINAL PAIN. THE PATIENT REPORTEDLY DID NOT RECEIVE ANY TREATMENT ABOVE OR BEYOND THE USUAL ROUTINE OF DIABETES CARE AND MANAGEMENT. THE REPORTER ALLEGED THE PATIENT¿S EVENT WAS DUE TO FREQUENT, PERSISTENT OCCLUSION ISSUES WITH THE INSULIN PUMP. TROUBLESHOOTING BY ANIMAS CUSTOMER TECHNICAL SUPPORT DETERMINED OCCLUSION OCCURRED DURING DELIVERY OF A BOLUS OF INSULIN; 0.95 UNITS OF A PROGRAMMED 1.95 UNITS WAS DELIVERED BEFORE THE OCCLUSION OCCURRED. AFTER CANCELLATION OF THE UNSUCCESSFUL BOLUS, THE CORRECT AMOUNT WAS REPORTEDLY DELIVERED. UPON REVIEW OF THE INFUSION SET INSERTION TECHNIQUE, ANIMAS CUSTOMER SUPPORT DETERMINED THE INFUSION SET INSERTION TECHNIQUE/MAINTENANCE WAS INCORRECTLY PERFORMED BY THE PATIENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY EXPERIENCED SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY DUE TO A TRAINING/MISUSE ISSUE RESULTING IN OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781758 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Life Threatening