BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2858881 · Received December 5, 2012

    Report

    Report Number
    2531779-2012-14246
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 8, 2012
    Report Date
    November 11, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    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. RECALL # 2531779-03/24/2010-003-R.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2012 ALLEGING THE PUMP EXPERIENCED A LOAD STEP MALFUNCTION WHEN THE PUMP EJECTED THE CONTENTS OF THE CARTRIDGE DURING THE LOAD STEP. THE PATIENT WAS CONFIRMED TO HAVE BEEN DISCONNECTED FROM THE PUMP AT THE TIME, BUT REPORTED HAVING LOW BLOOD GLUCOSE (BG) OF 29 MG/DL WITH ASSOCIATED SEVERE SWEATING AS A RESULT OF THE LOAD STEP MALFUNCTION. THE PATIENT STATED THAT SHE SELF-TREATED THE LOW BG WITH CONSUMPTION OF FOOD WITH RESOLUTION. THE PATIENT REPORTED, HER BG TO BE 97 MG/DL WITHOUT SYMPTOMS OF BG EXCURSION AT THE TIME OF THE CALL TO ANIMAS. THE PATIENT STATED THE PUMP DID NOT EMIT A "CARTRIDGE NOT DETECTED" WARNING WHEN THE ALLEGED LOAD STEP MALFUNCTION OCCURRED. THE PATIENT FURTHER REPORTED HAVING LOSS OF PRIME ISSUES WITH THE PUMP AND STATED THAT HER BG HAS HAD LOW EXCURSIONS FOR THE PAST WEEK. ANIMAS CUSTOMER TECHNICAL SUPPORT EXPLAINED TO THE PATIENT THAT IF SHE WAS NOT CONNECTED TO THE PUMP AT THE TIME THE LOAD STEP MALFUNCTION OCCURRED, SHE WOULD NOT HAVE EXPERIENCED A LOW BG EXCURSION BECAUSE NO INSULIN WOULD HAVE BEEN INFUSED; HOWEVER, THE PATIENT WAS ADAMANT THAT THE LOAD STEP MALFUNCTION WAS RESPONSIBLE FOR HER LOW BG EXCURSION. THE PATIENT DISCONTINUED INSULIN PUMP THERAPY AND BEGAN ON A BACKUP PLAN. THIS COMPLAINT IS BEING REPORTED BECAUSE, THE PATIENT ALLEGED THE PUMP EXPERIENCED A LOAD STEP MALFUNCTION, WHICH CAUSED HER TO HAVE LOW BG OF 29 MG/DL EVEN THOUGH THE PATIENT DENIED BEING ATTACHED TO THE PUMP AT THE TIME. THE ALLEGATION OF A LOAD STEP MALFUNCTION WAS NOT RESOLVED THROUGH TROUBLESHOOTING.

    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 57 YR Life Threatening| R