BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2072065 · Received April 28, 2011

    Report

    Report Number
    2531779-2011-02965
    Event Type
    Malfunction
    Date Received
    April 28, 2011
    Report Date
    April 1, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP # 1, 06/02/2011 - DEVICE EVALUATION: THE PUMP WAS RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 05/06/20110 WITH THE FOLLOWING FINDINGS: THE PUMP HISTORY SHOWED THAT ON (B)(6) 2011, A BLANK BASAL PROGRAM WAS ACTIVATED. THE PATIENT CHANGED THE TIME ON (B)(6) 2011 20:59 TO (B)(6) 2011 07:52. THE TOTAL DAILY DOSE WAS REVIEWED AND DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. THE PUMP ACCURATELY DELIVERS 2.00 UNITS/HR FOR 29-HR PERIOD. THERE WAS NO DEFECT FOUND DURING INVESTIGATIONS.

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURE DATE: 10/2010. THE PUMP HAS BEEN RETURNED TO ANIMAS; HOWEVER, THE INVESTIGATION HAS NOT BEEN COMPLETED. NO CONCLUSIONS CAN BE DRAWN AT THIS TIME. ONCE THE EVALUATION HAS BEEN COMPLETED A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PATIENT'S MOTHER CONTACTED ANIMAS (B)(4) TO REPORT THAT PUMP'S BASAL RATE PROGRAM WAS "WIPED OUT." THE REPORTER CLAIMED THAT ON (B)(6) 2011, THE PATIENT AWOKE WITH AN ELEVATED BLOOD GLUCOSE (BG) OF 18 MMOL/L (324 MG/DL). THE PATIENT'S MOTHER STATED THAT THE PATIENT HAD SOME NAUSEA; HOWEVER, DENIED THAT THE PATIENT DEVELOPED SYMPTOMS OF VOMITING, CHEST, OR ABDOMINAL PAIN. THE PATIENT WAS NOT TESTED FOR KETONES. THE PATIENT'S MOTHER REPORTED THAT SHE TREATED THE PATIENT FOR HIGH BG. WHEN SHE ENTERED THE A1 WEEKDAY BASAL PROGRAM, SHE ONLY SAW THE 12A TIME AND 00U NEXT TO IT. UNDER THE 12A WERE DASHES WITH NO ADDITIONAL TIMES OR BASAL RATES ENTERED. DURING TROUBLESHOOTING, THE REPORTER CONFIRMED SHE SET A TEMPORARY BASAL MINUS 20% AT 6:52PM ON (B)(6) 2011 FOR 2 HOURS. WHEN BASAL HISTORY REVIEWED IN PUMP, THE TEMPORARY BASAL APPEARED AND SHOWED THAT NORMAL BASAL RATE RESUMED AT 8:52PM. HOWEVER, AT 8:58PM BASAL RATE SHOWED 0.0U. IT WAS NOTED THAT THE PUMP WAS NOT SUSPENDED AND BASAL EDIT MENU AND PRIME MENU WERE NOT ENTERED. THE REPORTER CONFIRMED NO OTHER ASSOCIATED ALARMS APPEARED IN HISTORY. THE PATIENT'S MOTHER DENIED THAT THE CARTRIDGE WAS CHANGED OR BATTERY WAS REMOVED. TOTAL DAILY DELIVERY FOR BASAL FOR (B)(6) 2011 CONFIRMED 0U DELIVERED THROUGH THE NIGHT. THERE WAS NO ADVERSE EVENT ASSOCIATED WITH THIS COMPLAINT. THE PATIENT'S REPORTED BG READINGS AND SYMPTOMS DO NOT MEET ANIMAS' CRITERIA OF A SERIOUS INJURY. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED ISSUE REMAINED UNRESOLVED.

    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