BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2133973 · Received June 20, 2011

    Report

    Report Number
    2531779-2011-04281
    Event Type
    Injury
    Date Received
    June 20, 2011
    Report Date
    May 21, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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

    FOLLOW-UP # 1 DATE OF SUBMISSION (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: EVALUATION CONFIRMED THAT THE DISPLAY SCREEN WAS DIM AND DISCOLORED. A TEST DISPLAY WAS USED DURING TESTING. A REVIEW OF THE TOTAL DAILY DOSE HISTORY FROM (B)(6) 2011 TO THE END OF PUMP USE ON (B)(6) 2011 INDICATED THAT INSULIN DELIVERY TOTALS CORRECTLY REFLECTED PROGRAMMED VALUES. THERE WERE NO ALARMS OR CONDITIONS NOTED IN THE PUMP HISTORY THAT WOULD INDICATE A PUMP MALFUNCTION. THE PUMP WAS EXERCISED FOR 29 HOURS WITH NO INSULIN DELIVERY ISSUES. 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 REPORTED THAT HE EXPERIENCED A BLOOD GLUCOSE (BG) OF 33 MG/DL. HE STATED THAT HE SELF-TREATED WITH ORANGE JUICE AND HIS BG RESOLVED TO 81 MG/DL 30 MINUTES AFTER THE INCIDENT. THE PATIENT REPORTED THAT HIS BG AT THE TIME OF THE CALL TO CUSTOMER SUPPORT WAS 151 MG/DL. THE DATE OF THE EVENT WAS NOT REPORTED. HE STATED THAT HE MAY HAVE DELIVERED A LARGER BOLUS THAN INTENDED BECAUSE HE COULD NOT ADEQUATELY READ THE DISPLAY SCREEN; HE STATED THE DISPLAY SCREEN WAS DIM AND THE LETTERS WERE YELLOW. THE PATIENT REPORTED HE WAS EVENTUALLY ABLE TO REVIEW THE BOLUS HISTORY AND CONFIRMED THAT THE INTENDED BOLUS AMOUNT HAD BEEN PROGRAMMED AND DELIVERED ACCURATELY. HE ALSO CONFIRMED THAT THE TOTAL DAILY DOSE HISTORY WAS CORRECT. THE PATIENT HAS CONTINUED TO USE INSULIN PUMP THERAPY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT ALLEGEDLY EXPERIENCED HYPOGLYCEMIA WHILE USING THE PUMP. USE ERROR CANNOT BE RULED OUT AS A CAUSE OR CONTRIBUTOR TO THE ALLEGED HYPOGLYCEMIC EVENT BECAUSE THE PATIENT DELIVERED A BOLUS EVEN THOUGH HE COULD NOT ACCURATELY VIEW THE DISPLAY SCREEN. THE OWNER'S BOOKLET INSTRUCTS THE USER TO CALL ANIMAS CUSTOMER SERVICE IF THE USER SUSPECTS THAT THE PRODUCT IS DAMAGED.

    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 55 YR