BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 1822843 · Received August 30, 2010

    Report

    Report Number
    2531779-2010-01132
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 15, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THIS IS ADDITIONAL INFORMATION: FOLLOW-UP #2: DATE OF SUBMISSION: (B)(6) 2013-DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013, WITH THE FOLLOWING FINDINGS: THERE WAS ONE OCCLUSION ALARM OBSERVED IN THE BLACK BOX; THE OCCLUSION ALARM IS PRECEDED BY A CONSTANT RISE IN FORCE. THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. THE REWIND, LOAD CARTRIDGE, AND PRIME STEPS PERFORMED SUCCESSFULLY WITH NO ALARMS. A FORCE SENSOR CALIBRATION TEST CONFIRMED THE SENSOR IS DETECTING CORRECT FORCE. THE PUMP PASSED 29 HOUR FLOW ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. NO OCCLUSIONS OCCURRED DURING TESTING. AN OCCLUSION WAS INDUCED AND THE PUMP GIVES THE APPROPRIATE VISUAL AND AUDIBLE "OCCLUSION DETECTED" ALARM. THERE WAS CORROSION OBSERVED INSIDE BATTERY COMPARTMENT. A BATTERY COMPARTMENT LEAK WAS FOUND DURING LEAK TESTING. THE PUMP WAS OPENED AND NO FURTHER EVIDENCE OF MOISTURE DAMAGE WAS FOUND.

    Additional Manufacturer Narrative · 1

    DURING REVIEW OF THE PUMP, PT REPORTED THAT BOLUS CALCULATION SETTING MAY BE INCORRECT. THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. IF THE DEVICE IS RETURNED, AN EVAL SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    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: THE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED BASAL RATES. NO DATA IN BLACK BOX OR DOWNLOAD HISTORIES FROM TIME OF REPORTED HOSPITALIZATION DUE TO CONTINUED USE. THERE ARE NO PARTIAL BOLUSES IN PUMP HISTORY. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED; PUMP PASSED FLOW ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED SPECIFICATIONS. A NORMAL 10 UNIT BOLUS AND A 10 UNIT AUDIO BOLUS WERE PERFORMED SUCCESSFULLY AND BOTH WERE ACCURATELY RECORDED IN THE PUMP HISTORY. THE DISPLAY LENS WAS FOUND TO BE SCRATCHED.

    Description of Event or Problem · 1

    PT REPORTED HOSPITALIZATION FOR PNEUMONIA AND ELEVATED BLOOD GLUCOSE (1200 MG/DL).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. IR1250 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization