BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2171694 · Received July 22, 2011

    Report

    Report Number
    2531779-2011-05104
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 [DATE OF SUBMISSION (B)(4) 2011]-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 WARNS THAT CRACKS, CHIPS, OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND / OR THE WATERPROOF FEATURE OF THE PUMP. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE THE RESULTS WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. THE PUMP BATTERY COMPARTMENT WAS REPORTEDLY VISIBLY CRACKED. THE OWNER'S BOOKLET STATES THAT CRACKS, CHIPS OR DAMAGE TO THE PUMP MAY IMPACT THE BATTERY CONTACT AND TO CALL ANIMAS CUSTOMER SUPPORT IF YOU IDENTIFY OR SUSPECT THE PUMP HAS BEEN DAMAGED. THE OWNER'S BOOKLET ALSO STATES THAT THE BATTERY CAP MUST BE REPLACED EVERY SIX MONTHS. THE USER REPLACED THE BATTERY CAP OVER (B)(6) PRIOR TO CALLING ANIMAS. 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.

    Description of Event or Problem · 1

    THE PATIENT STATED THAT THE PUMP POWERED OFF ON (B)(6) AND SHE DID NOT NOTICE IT AT FIRST. SHE STATED THAT HER BLOOD GLUCOSE LEVELS SUBSEQUENTLY WENT UP TO 300 MG/DL WITH NAUSEA AND KETONES. THE PATIENT STATES THAT SHE FELT VERY ILL AND COULD NOT EAT. THE PATIENT SAID SHE STARTED ON A BACKUP PLAN OF INSULIN DELIVERY AND HER BLOOD GLUCOSE LEVELS HAVE REPORTEDLY RESOLVED TO A NORMAL RANGE. THE PATIENT NOTICED THAT THE PUMP'S BATTERY COMPARTMENT WAS CRACKED AND THE BATTERY CAP THREADS WERE STRIPPED. THE BATTERY CAP WAS REPLACED OVER (B)(6) AGO.

    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 16 YR Life Threatening| R