BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 4133859 · Received October 1, 2014

    Report

    Report Number
    2531779-2014-28092
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    September 20, 2014
    Report Date
    September 20, 2014
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS: THE DEVICE WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 01/23/2014 WITH THE FOLLOWING FINDINGS: THE COMPLAINT WAS UNABLE TO BE DUPLICATED OR CONFIRMED WITH INVESTIGATION. REVIEW OF THE PUMP¿S BLACK BOX REVEALED THE LAST BOLUS DELIVERY WAS PERFORMED ON (B)(6) 2014. THERE WERE NO ALARMS OR EVIDENCE OF ABNORMAL PUMP OPERATION. THE TOTAL DAILY DOSE HISTORY CORRELATES TO THE BASAL AND BOLUS HISTORIES. 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. 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 DEVICE HAS NOT BEEN REQUESTED FOR RETURN TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE REPORTER CONTACTED ANIMAS ALLEGING THE PATIENT¿S BLOOD GLUCOSE ON THE SAME DAY WAS UNSPECIFIED AND ABOVE 250 MG/DL WITH MODERATE KETONES AND VOMITING. IT WAS REPORTED THE PATIENT SELF-TREATED WITH AN INSERTION SITE CHANGE AND INSULIN VIA PUMP THERAPY, AND REMAINED ON PUMP THERAPY. THE REPORTER NOTED THE PATIENT SUFFERS FROM BIPOLAR DISORDER AND RECENTLY EXPERIENCED INCREASED LEVELS OF STRESS. NO ADDITIONAL INFORMATION WAS PROVIDED AND TROUBLESHOOTING COULD NOT BE PERFORMED. THIS COMPLAINT IS BEING REPORTED BASED ON THE ALLEGATION THAT THE PATIENT EXPERIENCED HYPERGLYCEMIA WHILE USING INSULIN PUMP THERAPY AND THE PUMP COULD NOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611709 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| R