BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2885912 · Received December 26, 2012

    Report

    Report Number
    2531779-2012-15017
    Event Type
    Injury
    Date Received
    December 26, 2012
    Report Date
    November 27, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. 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. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: 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: A REVIEW OF THE PUMP HISTORY REVEALED THE LAST BASAL DELIVERY WAS ON (B)(6) 2012, AT 10:23AM. A REVIEW OF THE PUMP BOLUS HISTORY REVEALED MULTIPLE CANCELED BOLUSES DUE TO "OCCLUSION" ALARMS ON (B)(6) 2012, WHICH IMMEDIATELY OCCURRED AFTER THE PROGRAMMED BOLUSES. A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. THE PUMP POWERED UP WITH NO ISSUES AND THE "EZ-PRIME" STEPS WERE SUCCESSFULLY PERFORMED ON THE PUMP. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO ALARMS NOTED. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION. PERIODIC BOLUSES WERE SUCCESSFULLY PERFORMED ON THE PUMP AND ACCURATELY RECORDED IN PUMP HISTORY. THE KEYPAD WAS FOUND TO BE INTACT AND RESPONSIVE TO USER INPUT. "OCCLUSION" ALARMS WERE TESTED AND THE PUMP GAVE THE APPROPRIATE VISUAL AND AUDIBLE ALERT. THE PUMP WAS OPENED AND NO DAMAGE WAS FOUND TO THE FORCE SENSOR OR ON THE POWER CIRCUITS. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. 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 CONTACTED ANIMAS ON (B)(6) 2012, REPORTING THAT THE WHEN THEY TRY TO BOLUS ON OCCASION THEY RECEIVE A CANCEL BOLUS FOR NO REASON BUT THEY ARE ABLE TO USUALLY COMPLETE. THE PATIENT REPORTED THAT THEIR BLOOD GLUCOSE (BG) WAS 200 TO 300'S WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA BUT WHEN THE BG LEVEL IS IN THE 300'S THEY HAVE INCREASED THIRST AND FREQUENT URINATION AND FEELING TIRED. THE PATIENT CONFIRMED THAT THEY DID NOT CANCEL THE BOLUS. TROUBLESHOOTING INDICATED THAT THERE WAS NO ASSOCIATED ALARMS OR OCCLUSION IN THE HISTORY. THE PATIENT WAS ABLE TO PRIME SUCCESSFULLY BUT UNABLE TO BOLUS. CUSTOMER SUPPORT HAS THE PATIENT CHANGE OUT THE TUBING AND SITE (USING A SET FROM A DIFFERENT BOX) AND THEY WERE ABLE TO PRIME SUCCESSFULLY. TROUBLESHOOTING ALSO INDICATED THAT THE EZ PRIMES STEPS WERE SUCCESSFULLY COMPLETED. THE PUMP HISTORY INDICATED THAT THE PATIENT RECEIVED INSULIN AND ALL SETTINGS WERE CORRECT. THIS REPORT IS BEING MADE BECAUSE THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED TO THE BLOOD GLUCOSE INCIDENT.

    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 47 YR Life Threatening