BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2247562 · Received September 14, 2011

    Report

    Report Number
    2531779-2011-06812
    Event Type
    Injury
    Date Received
    September 14, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 17, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. 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. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    A HOSPITAL STAFF MEMBER REPORTED THAT ON (B)(6) 2011, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR BLOOD GLUCOSE (BG) OF 46 MG/DL AND "ALTERED MENTAL STATUS". THE PATIENT WAS REPORTEDLY FOUND UNCONSCIOUS AT HOME ON (B)(6) 2011 AND WAS TAKEN TO THE HOSPITAL. THE PATIENT WAS REPORTEDLY REMOVED FROM THE PUMP UPON ARRIVAL AT THE HOSPITAL, AND RESUMED INSULIN PUMP THERAPY ON (B)(6) 2011. THE PATIENT'S BG WAS REPORTEDLY "LOW" ON ADMISSION TO THE HOSPITAL, AND WAS ERRATIC WHILE IN THE HOSPITAL, RANGING FROM 42 MG/DL TO 511 MG/DL. THE PATIENT WAS REPORTEDLY ON THE PUMP FOR BASAL DELIVERY OF INSULIN, AND WAS RECEIVING INSULIN INJECTIONS AS NEEDED FOR CORRECTIONS. THE PATIENT STATED THAT SHE HAS HYPOGLYCEMIA UNAWARENESS, CONGESTIVE HEART FAILURE (CFH), POOR RECALL, AND MEMORY LOSS. THE PATIENT STATED THAT SHE HAS HAD DECREASED ACTIVITY DUE TO THE CHF. SHE STATED THAT SHE HAS HAD A HISTORY OF FREQUENT LOW BGS OVER THE PAST SEVERAL YEARS. SHE ADMITTED THAT SHE WAS NOT BOLUSING FOR MEALS, AND WAS ONLY GIVING BOLUS CORRECTIONS POST-MEAL AS NEEDED IF HER BG WAS ELEVATED. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND FOUND THAT ALL SETTINGS AND HISTORIES WERE CORRECT. A REVIEW OF THE PUMP HISTORY CONFIRMED THAT THE PATIENT RARELY DELIVERED BOLUSES. THE PATIENT STATED THAT SHE SUCCESSFULLY PRIMED THE PUMP PRIOR TO THE CALL TO CS. THE PUMP HISTORY DID NOT REVEAL ANY ALARMS ASSOCIATED WITH THE REPORTED INCIDENT. THE PATIENT STATED THAT SHE WAS CHANGING HER SITE EVERY FOUR DAYS. THE USER GUIDE RECOMMENDS CHANGING THE SITE/SET EVERY TWO TO THREE DAYS. UPON FOLLOW-UP, THE PATIENT INDICATED THAT HER BGS HAD BEEN DECREASING OVER THE COURSE OF THE DAY ON (B)(6) 2011 AND HER BG RESOLVED TO 164 MG/DL. THE PUMP IS NOT BEING RETURNED AT THIS TIME, AND THERE HAS BEEN NO FURTHER REPORTED INCIDENT. THIS COMPLAINT IS BEING REPORTED DUE TO THE PATIENT'S ALLEGED HYPOGLYCEMIC EVENT WHILE USING 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 59 YR Hospitalization| L| R