BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2070890 · Received April 27, 2011

    Report

    Report Number
    2531779-2011-02920
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE: BRAND NAME: ANIMAS INSULIN CARTRIDGE. COMMON DEVICE NAME: INSULIN INFUSION PUMP CARTRIDGE. LOT # FOR CARTRIDGE: B201490. EXP FOR CARTRIDGE LOT: 02/28/2012. (B)(6). THE PUMP AND CARTRIDGE HAVE NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILLED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A RETAIN SAMPLE CARTRIDGE OF THE SAME LOT WAS TESTED ON (B)(4) 2011. THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2011. A VISUAL INSPECTION OF THE CARTRIDGE WAS PERFORMED. NO DAMAGE OR DEFECTS WERE NOTED. A LEAK TEST WAS PERFORMED WITH NO FAILURES OBSERVED. THE PUMP WAS FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES FOUND. A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR CONDITIONS NOTED IN THE HISTORY THAT WOULD INDICATE A PUMP MALFUNCTION. A REVIEW OF THE PUMP'S BOLUS HISTORY INDICATED THAT A BOLUS WAS SUCCESSFULLY DELIVERED AND ACCURATELY RECORDED ON (B)(6) 2011. DURING INVESTIGATION, A NORMAL BOLUS WAS PROGRAMMED, SUCCESSFULLY DELIVERED, AND RECORDED ACCURATELY INTO THE BOLUS HISTORY. THERE WERE NO ISSUES OBSERVED WITH THE PUMP'S BOLUS HISTORY. UNRELATED TO THE COMPLAINT, INVESTIGATION REVEALED A DISCOLORED DISPLAY SCREEN AND A SCRATCHED DISPLAY LENS, 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.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER AND FATHER CONTACTED ANIMAS TO REPORT THAT BOLUSES WERE NOT BEING RECORDED IN PUMP'S HISTORY, AND A CARTRIDGE WAS POSSIBLY LEAKING INSULIN. THE PATIENT'S MOTHER REPORTED THAT ON (B)(6), 2011 THE PATIENT OBTAINED AN ELEVATED BLOOD GLUCOSE (BG) READING OF 338 MG/DL. THE REPORTER DENIED THAT THE PATIENT DEVELOPED ANY SIGNS/SYMPTOMS OF HYPERGLYCEMIA. THE PATIENT'S MOTHER CLAIMED THE PATIENT INITIALLY BOLUSED WITH PUMP FOR HIGH BG; HOWEVER, WHEN READINGS DID NOT COME DOWN HE TOOK AN INJECTION AND BG CAME DOWN TO 273 MG/DL. THE PATIENT'S MOTHER DENIED THAT THE PATIENT RECEIVED ANY MEDICAL ATTENTION DUE TO HIGH BGS. THE REPORTED BG READING'S DO NOT MEET ANIMAS' CRITERIA OF A SERIOUS INJURY. AT THE TIME OF TROUBLESHOOTING, THE PATIENT'S MOTHER REPORTED THAT A WEEK PRIOR TO CALLING ANIMAS, DURING AN OFFICE VISIT, THE PATIENT'S HCP REVIEWED PUMP HISTORY AND NOTICED THAT BOLUSES HAD BEEN MISSED FOR APPROXIMATELY 1 MONTH. THE PATIENT'S FATHER CLAIMED THAT ON (B)(6) 2011 WHEN CHANGING OUT CARTRIDGE/SITE/SET, THEY NOTICED A STRONG SMELL OF INSULIN INSIDE THE PUMP'S CARTRIDGE COMPARTMENT. THE PATIENT'S FATHER DENIED ANY ISSUES WITH BENT CANNULAS OR EVIDENCE OF INSULIN LEAKING AT SITE. AT THE TIME OF THE CALL, THE PATIENT'S FATHER CONFIRMED THERE WAS NO MOISTURE IN THE PUMP'S COMPARTMENT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THESE COMPLAINTS; HOWEVER, THESE COMPLAINTS ARE BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED AT THE TIME OF TROUBLESHOOTING.

    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