BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2223767 · Received August 25, 2011

    Report

    Report Number
    2531779-2011-06224
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Report Date
    July 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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) 2011 WITH THE FOLLOWING FINDINGS: VISUAL INSPECTION REVEALED THAT THE BATTERY CAP THREADS ARE STRIPPED AND THE CAP WILL NOT SECURE PROPERLY TO THE PUMP, CAUSING DISRUPTION OF POWER. EVALUATION REVEALED A BROKEN CONTACT ON THE BATTERY CAP. THERE WAS NO DAMAGE NOTED TO THE BATTERY COMPARTMENT. A TEST BATTERY CAP WAS USED TO COMPLETE INVESTIGATION. THE PUMP POWERS ON APPROPRIATELY TO THE VERIFICATION SCREEN. A REVIEW OF THE PUMP HISTORY INDICATED THAT REBOOTING HAD OCCURRED, WHICH COULD NOT BE DUPLICATED DURING TESTING; THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO POWER ISSUES OCCURRING. A DAMAGED BATTERY CAP IS NOT LIKELY TO CAUSE AN ADVERSE EVENT, AS THE ISSUE IS GENERALLY OBVIOUS AND DETECTABLE BY THE USER. THEREFORE THE DETECTABLE FLAW MAY PREVENT THE USER FROM CONTINUING USE OF THE DEVICE OR CAUSE A CONDITION THAT MAKES CONTINUED USE OF THE DEVICE IMPOSSIBLE. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A DISCOLORED DISPLAY SCREEN, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED. THE REPORT WAS SUBMITTED AS AN ADVERSE EVENT AND PRODUCT PROBLEM. THE PATIENT REPORTED BLOOD GLUCOSE (BG) UP TO 457 MG/DL WITH NO SIGNS OR SYMPTOMS OF HYPERGLYCEMIA. THE REPORTED BG EXCURSION DOES NOT MEET THE DEFINITION OF A SERIOUS INJURY. THE COMPLAINT SHOULD HAVE BEEN REPORTED AS A PRODUCT PROBLEM ONLY FOR THE ALLEGED INTERMITTENT POWER LOSS.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. 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. THE REPORT IS 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 CLAIMED THE ANIMAS PUMP HAS AN INTERMITTENTLY POWER ISSUE. REPORTEDLY, THE PUMP HAS SELF REBOOTED SEVERAL TIMES IN THE PAST AND TWICE DURING THE PHONE CALL TO ANIMAS. THE BATTERY CAP AND COMPARTMENT WAS NOT DAMAGED. THE BATTERY COMPARTMENT WAS CORROSION FREE. THE BATTERY CAP FITS TIGHTLY ON THE PUMP. THE BATTERY WAS REPLACED, BUT THE ISSUE WAS NOT RESOLVED WITH TRAINING. THERE WAS NO EVIDENCE OF PRODUCT MISUSE. THE PRODUCT WAS SENT BACK FOR INVESTIGATION. IN ADDITION, THE PATIENT INDICATED SINCE THE SUBJECT PUMP HAS BEEN REBOOTING, THERE HAS BEEN MORE ELEVATED BLOOD GLUCOSE. REPORTEDLY, HE TOOK 20 UNITS TO CORRECT AN ELEVATED BLOOD GLUCOSE READING OF 457 MG/DL. THE PATIENT DID NOT HAVE ANY SYMPTOMS OF KETONES, NAUSEA, AND VOMITING. THE LAST HIGH BLOOD GLUCOSE THE PATIENT OBTAINED ON (B)(6) 2011, HE TOOK 25 UNITS OF INSULIN VIA THE ANIMAS PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT RECEIVED TREATMENT SUGGESTIVE OF HYPERGLYCEMIA WHILE HE MANAGED HIS DIABETES WITH THE ANIMAS PUMP AND HAD POWER ISSUES.

    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 Life Threatening| R