BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2132189 · Received June 17, 2011

    Report

    Report Number
    2531779-2011-04240
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    April 11, 2011
    Report Date
    May 20, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(4) 2011. DEVICE HISTORY RECORD REVIEW WAS CONDUCTED ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS. 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. 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

    THE PATIENT REPORTED THAT ON (B)(6) 2011 SHE EXPERIENCED BLOOD GLUCOSE (BG) LESS THAN 20 MG/DL WITH UNCONSCIOUSNESS. THE PATIENT WAS SUBSEQUENTLY TAKEN TO THE HOSPITAL AND TREATED; AFTER TREATMENT HER BG REPORTEDLY ELEVATED TO 423 MG/DL. THE PATIENT STATED THAT HER ENDOCRINOLOGIST HAD DECREASED HER INSULIN TO CARBOHYDRATE RATIO (I:C), DECREASED HER INSULIN SENSITIVITY FACTOR (ISF), AND INCREASED HER TARGET BG; HOWEVER SHE STATED THAT SHE HAD NOT MADE THESE CHANGES IN THE PUMP SETTINGS, AND HAD BEEN PERFORMING MANUAL CALCULATIONS HERSELF FOR INSULIN DELIVERY. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP HISTORY WITH THE PATIENT AND FOUND THAT THE PUMP WAS LAST PRIMED ON (B)(6) 2011; THERE WERE NO ASSOCIATED ALARMS IN THE HISTORY; AND THE HISTORY INDICATED THAT THE PATIENT HAD PROGRAMMED INCREASED BOLUS AMOUNTS ON THE DAY OF THE REPORTED INCIDENT. THE PATIENT WAS UNSURE WHAT THE REASON WAS FOR THE INCREASED BOLUSES. THE PATIENT REPORTED THAT SHE WAS ALSO UNDERGOING CHEMOTHERAPY. THE PUMP IS NOT BEING RETURNED AT THIS TIME. THE PATIENT RESUMED INSULIN PUMP THERAPY WITHOUT FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED HYPOGLYCEMIA 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 65 YR Hospitalization