BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 6140369 · Received December 1, 2016

    Report

    Report Number
    2531779-2016-32687
    Event Type
    Injury
    Date Received
    December 1, 2016
    Report Date
    November 6, 2016
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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

    THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 02/23/2017 WITH THE FOLLOWING FINDINGS: THE COMPLAINT COULD NOT BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. DATA RELEVANT TO THE ALLEGED EVENT WAS OVERWRITTEN DUE TO EXTENDED PUMP USE. REVIEW OF THE PUMP¿S BLACK BOX INDICATED A LOSS OF PRIME THAT OCCURRED ON 11/13/2016. THE TOTAL DAILY DOSE HISTORY WAS APPROPRIATE FOR THE USER PROGRAMMED DELIVERY SETTINGS. THE PUMP SUCCESSFULLY COMPLETED A PRIME SEQUENCE, BOLUS DELIVERIES, AND 24-HOUR EXERCISE TEST WITHOUT ISSUE OR ALARM. THE PUMP PASSED A DELIVERY ACCURACY TEST. THE PUMP'S FORCE SENSOR CALIBRATION WAS FOUND TO BE WITHIN SPECIFICATION. THERE WAS NO DAMAGE OR DEFECT FOUND TO THE FORCE SENSOR COMPONENTS/CIRCUIT.

    Description of Event or Problem · 1

    THE REPORTER CONTACTED ANIMAS ON (B)(6) 2016 ALLEGING THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY WITH BLOOD GLUCOSE MEASURING 479 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 STATED THE PUMP EXPERIENCED A LOSS OF PRIME ONE TIME AS A RESULT OF A TRAINING/MISUSE ISSUE INVOLVING AN ENVIRONMENTAL OR ACTIVITY ISSUE; EITHER AN IMPACT TO THE PUMP (DROPPED) OR A SUDDEN CHANGE IN TEMPERATURE (OUTSIDE NORMAL OPERATING TEMPERATURE RANGE.) THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A SERIOUS INJURY WHILE ON INSULIN PUMP THERAPY DUE TO TRAINING/MISUSE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790138 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR