BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2110406 · Received June 1, 2011

    Report

    Report Number
    2531779-2011-03850
    Event Type
    Injury
    Date Received
    June 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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

    THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: THE PUMP WAS EVALUATED AND FOUND TO BE DELIVERING INSULIN ACCURATELY. NO DEFECTS RELATED TO THE EVENT. UNRELATED TO THE EVENT THE BATTERY COMPARTMENT WAS FOUND TO BE CRACKED AND THE DISPLAY WAS FOUND TO HAVE A RED TINT. 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 ON (B)(6) 2011 SHE WENT TO BED WITH A BLOOD GLUCOSE (BG) OF 80MG/DL. SHE STATED SHE HAD A SMALL AMOUNT OF JUICE AND SLEPT THROUGH THE NIGHT. ON (B)(6) 2011 HER BG WAS 300MG/DL WITH AN ELEVATED HEART RATE AND SHORTNESS OF BREATH. SHE REPORTED THAT SHE CHANGED HER SITE AND GAVE HERSELF A CORRECTION BOLUS AND HER BG RETURNED TO NORMAL RANGE WITHOUT FURTHER INCIDENT. THE PATIENT ALSO REPORTED THAT THERE MAY HAVE BEEN AN AIR BUBBLE IN THE CARTRIDGE BUT UNABLE TO DETERMINE AT THE TIME OF THE CALL. THIS COMPLAINT IS BEING REPORTED BECAUSE OF THE PATIENT'S HYPERGLYCEMIA.

    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 32 YR Life Threatening