BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2161867 · Received July 14, 2011

    Report

    Report Number
    2531779-2011-04940
    Event Type
    Injury
    Date Received
    July 14, 2011
    Report Date
    June 16, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO ANIMAS. EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION 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 07/26/2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE PUMP HISTORY INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THE PUMP HISTORY INDICATED THE FOLLOWING: MULTIPLE OCCLUSION ALARMS OCCURRED; AN EMPTY CARTRIDGE ALARM OCCURRED AT 1:34 PM ON (B)(4) 2011 AND A NEW CARTRIDGE WAS NOT LOADED UNTIL 9:46 PM ON (B)(4) 2011; THE DATE WAS MANUALLY CHANGED FROM (B)(4) 2011 TO (B)(4) 2011. DURING INVESTIGATION, REWIND, LOAD, AND PRIME STEPS WERE SUCCESSFULLY PERFORMED WITH NO ALARMS OCCURRING. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO ALARMS AND NO INSULIN DELIVERY ISSUES. AN OCCLUSION WAS INDUCED DURING TESTING AND THE PUMP EMITTED THE APPROPRIATE AUDIOVISUAL ALERTS. THE PUMP WAS FOUND TO BE ALARMING APPROPRIATELY; THE ALLEGED MALFUNCTION IS NOT LIKELY TO CAUSE AN ADVERSE EVENT BECAUSE THE PUMP WILL ALARM TO ALERT THE USER OF THE ISSUE. THE OWNER'S BOOKLET INSTRUCTS THE USER TO BE PREPARED TO GIVE HIS OR HERSELF AN INJECTION OF INSULIN IF DELIVERY IS INTERRUPTED FOR ANY REASON. UNRELATED TO THE COMPLAINT, EVALUATION REVEALED A CRACKED BATTERY COMPARTMENT, WHICH HAS NO EFFECT ON INSULIN DELIVERY FUNCTION. 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. 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. THERE WERE NO INSULIN DELIVERY ISSUES FOUND ON INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT SHE EXPERIENCED BLOOD GLUCOSE (BG) OF 400MG/DL TO HI WITH NAUSEA. SHE REPORTEDLY WAS TAKEN TO THE EMERGENCY ROOM AND TREATED WITH TWO LITERS OF INTRAVENOUS FLUIDS AND DISCHARGED HOME. THE PATIENT REPORTED THAT THE RECEIVED MULTIPLE OCCLUSION ALARMS WITH THE PUMP AND THAT THE PUMP CASING WAS CRACKED. CUSTOMER SUPPORT INSTRUCTED THE PATIENT TO CALL HER HEALTHCARE PROFESSIONAL FOR A BACK-UP PLAN. THIS REPORT IS BEING MADE DUE TO THE PATIENT'S ALLEGED HYPERGLYCEMIC EVENT WHILE ON INSULIN PUMP THERAPY.

    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 21 YR Required Intervention