BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2221537 · Received August 24, 2011

    Report

    Report Number
    2531779-2011-06164
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP POWERED ON APPROPRIATELY TO THE VERIFICATION SCREEN WITH FUNCTIONAL AUDITORY AND VIBRATORY ALARMS. THEY KEYPAD WAS FOUND TO BE FUNCTIONING APPROPRIATELY. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. TESTING COULD NOT BE ADEQUATELY COMPLETED DUE TO A CALL SERVICE ALARM OCCURRING DURING THE REWIND, LOAD, AND PRIME SEQUENCE. A REVIEW OF THE PUMP HISTORY INDICATED THAT THE SAME ALARM HAD OCCURRED MULTIPLE TIMES SINCE (B)(6) 2011 DURING THE ALIGN STEP. THE MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. EVALUATION REVEALED THAT THERE WAS AN INTERMITTENT PCB FAILURE.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT ON AN UNSPECIFIED DATE THE PATIENT OBTAINED A FASTING BLOOD GLUCOSE RESULT OF 522 MG/DL. THE PATIENT NOTED SHE HAD NOT TESTED HER BLOOD GLUCOSE LEVEL PRIOR TO GOING TO BED THE NIGHT BEFORE. THE PATIENT CHANGED THE INFUSION SITE AND USED THE PUMP TO CALCULATE BOLUS DOSES. THE PATIENT CONTACTED HER HCP, WHO INSTRUCTED THE PATIENT TO USE THE TEMPORARY BASAL SETTINGS TO GIVE HERSELF ADDITIONAL INSULIN. THE PATIENT'S SUBSEQUENT BLOOD GLUCOSE READING WAS 64 MG/DL, AND SHE SUFFERED A MIGRAINE HEADACHE. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR TREATMENT OF THE MIGRAINE HEADACHE. THE PATIENT REFUSED TO TROUBLESHOOT THE PUMP, THEREFORE IT IS NOT POSSIBLE TO DETERMINE IF THE PUMP WAS FUNCTIONING CORRECTLY. IT WOULD HAVE BEEN HELPFUL TO DETERMINE THE EVENTS OF THE DAY PRIOR TO THIS, THE PATIENT'S BLOOD GLUCOSE READING ON THE DAY PRIOR, THE INSULIN DOSES TAKEN, THE PATIENT'S TECHNIQUE AND THE PUMP SETTINGS USED. HOWEVER, AS THE PATIENT EXPERIENCED BLOOD GLUCOSE LEVELS INDICATIVE OF SEVERE INJURY WHILE USING THE PUMP, AND RECEIVED EMERGENCY TREATMENT AND HOSPITALIZATION, THIS COMPLAINT IS BEING REPORTED.

    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 32 YR Hospitalization| L