BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2140985 · Received June 27, 2011

    Report

    Report Number
    2531779-2011-04487
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011 WITH THE FOLLOWING FINDINGS: THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED. THE USER GUIDE INSTRUCTS THE PATIENT THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. THE BATTERY CAP WAS UNABLE TO BE FASTENED SECURELY; THE BATTERY CAP KEPT SPINNING UNTIL THE PUMP REBOOTED. A TEST CAP WAS INSERTED WITH THE SAME RESULT. A REVIEW OF THE PUMP BLACK BOX SHOWED SEVERAL REBOOTS HAD OCCURRED. THE PUMP WAS EXERCISED FOR 24 HOURS WITHOUT REBOOTING.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THE PUMP HAS BEEN INTERMITTENTLY SELF-REBOOTING. SHE STATED THAT THIS OCCURRED MULTIPLE TIMES IN (B)(6) 2011, AND NOW IT IS OCCURRING ONCE EVERY TWO TO THREE WEEKS. THE PATIENT NOTED THAT THE PUMP LAST SELF-REBOOTED ON (B)(6) 2011. SHE STATED THAT SHE HAS BEEN ABLE TO CONFIRM THE VERIFY SCREEN AND COMPLETE THE REWIND, LOAD, AND PRIME SEQUENCE AFTER REBOOTING OCCURS. THE PATIENT CONFIRMED THAT THE PUMP AND BATTERY CAP ARE INTACT; THERE WERE NO CRACKS OR VISIBLE DAMAGE TO THE THREADS. SHE STATED THAT THE BATTERY CAP IS ORIGINAL TO THE PUMP, FROM (B)(6) 2008. THE USER GUIDE RECOMMENDS CHANGING THE BATTERY CAP EVERY SIX MONTHS. THE PATIENT STATED THAT THE PUMP HAD NOT BEEN EXPOSED TO MOISTURE, AND REPORTED THAT SHE HAD BEEN WEARING THE PUMP IN HER POCKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ANM 1250 INSULIN INFUSION PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR