BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2082377 · Received May 9, 2011

    Report

    Report Number
    2531779-2011-03252
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 12, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1 (B)(6) 2011 - DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(6) 2011 WITH THE FOLLOWING FINDINGS: A REVIEW OF TOTAL DAILY DOSE HISTORY FROM (B)(6) 2010 TO END OF PUMP USE ON (B)(6) 2011 SHOWED THAT DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECTED THE USER PROGRAMMED BASAL RATES. A 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING INSULIN WITHIN SPECIFICATIONS. DURING INVESTIGATION A 10 UNIT BOLUS WAS PROGRAMMED AND CORRECTLY RECORDING IN THE PUMP'S BOLUS HISTORY. UNRELATED TO THE COMPLAINT, THE PUMP'S DISPLAY SCREEN WAS FOUND TO BE DIM WITH A RED TINT.

    Additional Manufacturer Narrative · 1

    AFTER THE EVALUATION IS COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE REPORTER CLAIMED THAT THE PATIENT'S BLOOD GLUCOSE HAS BEEN ELEVATED TO 300-400 MG/DL AND HIS (B)(6) WHILE THE ANIMAS PUMP HAS HAD ONGOING ISSUES WITH MISSING DATA AND INSULIN DELIVERY. THE PUMP ISSUE BEGAN IN (B)(6) 2011. REPORTEDLY, THE PATIENT WAS HOSPITALIZED IN (B)(6) FOR HYPERGLYCEMIA, FEVER, AND THE FLU. AT THE TIME OF CONCERN, THE PATIENT DID NOT HAVE ANY SYMPTOMS OF HYPERGLYCEMIA OR HYPERGLYCEMIA. DURING TROUBLESHOOTING, THE ANIMAS REPRESENTATIVE NOTED THE FOLLOWING: THERE ARE NO ALARMS IN ALARM HISTORY, NO ISSUE WITH SITES, AND NO BUBBLES IN CARTRIDGES. THE SITE WAS NOT LEAKING. THERE WAS NO CHANGE IN ACTIVITY, NO ISSUE WITH INSULIN AND NO NEW MEDS. HOWEVER, THE BASAL HISTORY DOES NOT SHOW ALL THE BASAL CHANGES AT 3PM AND 6PM IN BASAL HISTORY CONSISTENTLY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY HAD ELEVATED BLOOD GLUCOSE AND WAS HOSPITALIZED WHILE MANAGING HIS/HER BLOOD GLUCOSE WITH THE ANIMAS PRODUCT.

    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 11 YR Hospitalization| L