BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3180096 · Received June 20, 2013

    Report

    Report Number
    2531779-2013-08620
    Event Type
    Injury
    Date Received
    June 20, 2013
    Report Date
    May 22, 2013
    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

    (B)(4) - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE BLACK BOX SHOWED THE LAST BASAL DELIVERY AND BOLUS WERE RECORDED ON (B)(4) 2013. THE USER¿S PROGRAMMED BASAL RATES WERE CORRECTLY REFLECTED IN THE DAILY INSULIN DELIVERY TOTALS. THERE WERE NO RELATED ALARMS IN THE HISTORY; ONLY TYPICAL USAGE WAS OBSERVED. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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 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.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE LAY-USER/PATIENT CONTACTED ANIMAS TO REPORT SHE HAD UNEXPLAINED BLOOD GLUCOSE READING RESULT OVER 500 MG/DL AND WAS HOSPITALIZED. ON (B)(6) 2013, THE PATIENT FELL IN THE BATHROOM AND REMAINED THERE ON THE FLOOR FOR AT LEAST ONE DAY BEFORE SHE WAS TAKEN TO THE HOSPITAL. THE PATIENT ATTRIBUTED HER FALL TO THE KNEE INJURY. THE PATIENT COULD NOT PROVIDE ANY BLOOD GLUCOSE PRIOR TO THE INCIDENT. THERE WERE NO SYMPTOMS DURING THE HYPERGLYCEMIC EPISODE. REPORTEDLY, HER FRIEND FOUND HER ON THE BATHROOM FLOOR AND CALLED THE AMBULANCE AT THE TIME OF CONCERN. THE HOSPITAL TREATED THE PATIENT WITH IV INSULIN DRIP AND WAS RELEASED FROM THE HOSPITAL ON INSULIN PUMP THERAPY. TROUBLESHOOTING INDICATED THAT THE DATE AND TIME, BASAL SETTING, ADVANCE FEATURES WERE PROGRAMMED ACCORDINGLY. THE BOLUS AND TOTAL DAILY DOSE WERE ACCOUNTED FOR. THE PATIENT DID NOT TAKE ANY BOLUS INSULIN ON (B)(6) 2013. THERE WAS NO PRODUCT MALFUNCTION ASSOCIATED WITH THE REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT WAS TREATED FOR HYPERGLYCEMIA WHILE ON INSULIN PUMP THERAPY. ALTHOUGH THERE WAS NO INDICATION THE ANIMAS PRODUCTS MALFUNCTIONED, USE ERROR AND INTENTIONAL MISUSE COULD NOT RULE OUT AS A CONTRIBUTOR THE REPORTED INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279952 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| L| R