BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2201080 · Received August 11, 2011

    Report

    Report Number
    2531779-2011-05787
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. 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. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Description of Event or Problem · 1

    A FAMILY MEMBER REPORTED THAT ON (B)(6) 2011 THE PATIENT EXPERIENCED BLOOD GLUCOSE (BG) OF 74 MG/DL WITH DISORIENTATION. THE FAMILY MEMBER STATED THAT THE PATIENT WAS TREATED WITH A GLUCAGON INJECTION AND WAS TAKEN TO THE HOSPITAL. A REVIEW OF THE PUMP HISTORY INDICATED THAT FOUR BOLUSES WERE DELIVERED WITHIN MINUTES OF EACH OTHER VIA THE AUDIO BOLUS FEATURE. THE FAMILY MEMBER STATED THAT HE WAS UNSURE IF THE PATIENT KNEW HOW TO APPROPRIATELY USE THIS FEATURE. HE REPORTED THAT THE PATIENT'S BG WAS 205 MG/DL AT THE TIME OF THE CALL TO CUSTOMER SUPPORT (CS). CS CONCLUDED THAT THE PATIENT'S BG EXCURSION WAS DUE TO USE ERROR IN DELIVERING MULTIPLE BOLUSES IN A SHORT PERIOD OF TIME. CS ASSISTED THE FAMILY MEMBER IN TURNING THE AUDIO BOLUS FEATURE OFF. THE PUMP IS NOT BEING RETURNED AT THIS TIME; THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 2020 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Hospitalization| R