BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2083490 · Received May 10, 2011

    Report

    Report Number
    2531779-2011-03304
    Event Type
    Injury
    Date Received
    May 10, 2011
    Date of Event
    April 10, 2011
    Report Date
    April 10, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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. 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

    DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN ACCORDING TO SPECIFICATIONS. THE TOTAL DAILY DELIVERY HISTORY CORRECTLY REFLECTS THE USER PROGRAMMED BASAL RATES. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED WITH BLOOD GLUCOSE (BG) READING OF 396 MG/DL WITH EMESIS AND URINARY KETONES; NO DIAGNOSIS WAS PROVIDED. A FAMILY MEMBER REPORTED THAT SHE DELIVERED INSULIN INJECTIONS VIA SYRINGE UNDER THE SUPERVISION OF THE DIABETES EDUCATOR. SHE STATED THAT THE PATIENT¿S BG DID NOT RESPOND TO INJECTIONS AND A NEW VIAL OF INSULIN WAS PROVIDED. THE PATIENT WAS DISCHARGED WITH BG OF 250 MG/DL. THE FAMILY MEMBER REPORTED THAT THE PATIENT'S BG CONTINUED TO BE ELEVATED BETWEEN 200 MG/DL AND 502 MG/DL DURING THE PAST WEEK. THE FAMILY MEMBER REVIEWED THE PUMP WITH CUSTOMER SUPPORT WITH THE FOLLOWING RESULTS. THE TIME AND DATE WERE CORRECT. THERE WERE NO RELEVANT ALARMS AND NO TEMPORARY BASAL RATES. THERE WERE MINOR DISCREPANCIES IN THE BASAL AND BOLUS DELIVERY AMOUNTS. ALL SETTINGS ARE CORRECTLY PROGRAMMED EXCEPT FOR ONE BOLUS SETTING WHEREBY THE PATIENT RECEIVED LESS INSULIN THAN EXPECTED. THE INFUSION SITES WERE CLEAR WITHOUT LEAKAGE, REDNESS, OR IRRITATION. NO LEAKAGE OR AIR BUBBLES FOUND IN THE TUBING OR CARTRIDGE. THE FAMILY MEMBER REPORTED THAT THE PATIENT CONTINUED TO USE THE PUMP AND BG READINGS WERE 140 MG/DL TO HI (>600 MG/DL) AFTER LUNCH. SHE SAID THAT THE PATIENT HAD AN APPOINTMENT WITH HER PHYSICIAN AND DIABETES EDUCATOR TO REVIEW PUMP SETTINGS. THIS COMPLAINT IS BEING REPORTED BECAUSE A PUMP MALFUNCTION CANNOT BE RULED OUT AT THIS TIME.

    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 8 YR Hospitalization