BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3163041 · Received June 11, 2013

    Report

    Report Number
    2531779-2013-08103
    Event Type
    Injury
    Date Received
    June 11, 2013
    Report Date
    May 15, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS. 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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1: DATE OF SUBMISSION 12/08/2015 DEVICE EVALUATION: THE DEVICE HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON 11/24/2015 WITH THE FOLLOWING FINDINGS: UNABLE TO DUPLICATE THE COMPLAINT, THE PUMP INFORMATION FOR THE COMPLAINT DATE HAS BEEN OVERWRITTEN. THE BLACK BOX BEGINS ON (B)(6) 2014. DUE TO CONTINUOUS USE OF THE PUMP THE BLACK BOX DATA/HISTORIES FOR THE EVENT HAVE BEEN OVERWRITTEN. AVAILABLE DAILY INSULIN DELIVERY TOTALS CORRECTLY REFLECT THE USERS PROGRAMMED BASAL RATES. PUMP PASSED DELIVERY ACCURACY TEST AND FOUND TO BE DELIVERING WITHIN REQUIRED RANGE AND DELIVERING ACCURATELY. 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

    ON (B)(6) 2013, THE REPORTER CONTACTED ANIMAS AND ALLEGED THAT HE HAS EXPERIENCED FLUCTUATING BLOOD GLUCOSE (BG) LEVELS: A LOW OF 38 MG/DL WITH SYMPTOMS OF DIZZINESS AND SHAKINESS, AND BG UP TO 400 MG/DL WITH FREQUENT URINATION. PATIENT WAS ABLE TO BRING BG DOWN ON HIS OWN WITH BOLUSES, AND WAS ABLE TO INCREASE BG IF NEEDED BY INCREASED FOOD INTAKE. MD HAS REVIEWED PUMP HISTORY AND FOUND NO ISSUES. NO ALARMS/OCCLUSIONS REPORTED AT ALL. STATES THAT HE HAS SEEN ENDOCRINOLOGIST AND THEY HAVE NOT BEEN ABLE TO DETERMINE WHAT THE REASON IS FOR THESE ISSUES. PATIENT DOES NOT FEEL THE NEED TO TROUBLESHOOT AT THIS TIME. CONFIRMS ALL SETTINGS ARE CORRECT. CUSTOMER SUPPORT (CS) INSTRUCTED PATIENT TO GO TO ALTERNATE DELIVERY METHOD IF HE FEELS THAT PUMP FUNCTION MAY BE AN ISSUE. EDUCATED THAT THERE ARE NO REASONS FOUND THAT PUMP WOULD BE CAUSING BG ISSUES, BUT IF ISSUE CONTINUES AND NO REASON FOUND HE SHOULD COME OFF OF PUMP. NO ISSUES WERE FOUND WITH PUMP AND PATIENT WAS NOT BLAMING PUMP. PATIENT WAS INSTRUCTED TO DISCUSS BG ISSUES WITH HCP AND TO CALL CTS BACK IF HE HAS ANY ADDITIONAL CONCERNS. ALTHOUGH NO SPECIFIC EVIDENCE OF PUMP MALFUNCTION, DEFECT, OR MISUSE WAS DETECTED, THIS REPORT IS BEING MADE DUE TO THE POSSIBILITY THAT THE USE OF AN INSULIN PUMP MAY HAVE CONTRIBUTED IN AN UNIDENTIFIED MANNER TO THE BLOOD GLUCOSE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    264241 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Life Threatening