BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2830153 · Received November 13, 2012

    Report

    Report Number
    2531779-2012-13511
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 17, 2012
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    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

    ON (B)(6) 2012, THE LAY-USER/PATIENT CONTACTED ANIMAS (ANM) AND REPORTED ELEVATED BLOOD GLUCOSE (BG) LEVELS. THE PATIENT INDICATED THAT SHE HAD BEEN GETTING UNSPECIFIED HIGH READINGS ON HER METER, AND WAS SICK AND VOMITING FOR TWO WEEKS. ACCORDING TO THE PATIENT, SHE WAS SUPPOSED TO HAVE A FEW MEDICAL PROCEDURES PERFORMED DURING THE TIME OF CONCERN. IN ONE EPISODE TWO WEEKS PRIOR TO CONTACTING ANM ON (B)(6) 2012, THE PATIENT WOKE UP FEELING DRUNK ALTHOUGH SHE DENIED DRINKING. SHE REPORTED RAN AN ERROR FEELING DRUNK AND BEGAN THROWING UP WHILE DRIVING. DURING THE ERRAND, THE PATIENT DROVE FEELING DIZZY. IN ANOTHER INSTANCE, THE PATIENT, WHO IS ON DIALYSIS, WAS SUPPOSED TO HAVE A PROCEDURE DONE ON HER FISTULA. HOWEVER, THE PATIENT STATED THAT SHE WAS NOT TREATED BECAUSE OF THE HIGH BG ELEVATIONS. THE PATIENT MENTIONED THAT HER HEALTH CARE PROVIDER (HCP) CHANGED INCREASED HER BASAL RATES A DAY EARLIER ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS ALSO VOMITING. AT THE TIME OF CONTACT WITH ANM, THE PATIENT CLAIMED THAT HER CURRENT BG LEVEL WAS STILL HIGH ALTHOUGH SHE WAS NO LONGER VOMITING OR NAUSEATED. SHE WAS GOING TO VISIT HER HCP THE FOLLOWING DAY ON (B)(6) 2012. AT THIS TIME, NO SUBSEQUENT BG EXCURSIONS HAVE BEEN REPORTED TO ANM BY THE PATIENT. THE PATIENT MENTIONED THAT SHE DID NOT DO ANY BOLUS ON (B)(6) 2012, AFTER 1100 AM. SHE EXPLAINED THAT SHE WAS AFRAID OF TAKING TOO MUCH INSULIN ALTHOUGH HER BG'S WERE READING HIGH ON HER METER. THE PATIENT DID NOT REPORT SEEKING OR RECEIVING MEDICAL INTERVENTION DURING THE TIME OF CONCERN. THROUGH TROUBLESHOOTING, THE ANM REPRESENTATIVE INVOLVED IN THIS CONTACT NOTED THAT THE PUMP PRIMED EASILY INTO THE AIR. THE PATIENT DENIED HAVING BENT CANNULAS OR LEAKAGE/BUBBLE ISSUES. NO RELEVANT ALARMS WERE OBSERVED IN THE PUMP'S ALARM HISTORY. THE PUMP'S TIME AND DATE WERE REPORTEDLY CORRECT. THE ANM REPRESENTATIVE NOTED THAT NO MECHANICAL ISSUES WERE FOUND WITH REVIEW OF THE PUMP. THE PATIENT WAS ADVISED NOT TO DRIVE WHILE FEELING DIZZY. SHE WAS ALSO RECOMMENDED TO LET HER HCP KNOW OF WHAT WAS GOING ON AND TO CALL 911 IF SHE EXPERIENCED ANY MORE DIZZINESS, VOMITING, OR NAUSEA. BASED ON THE INFORMATION PROVIDED, THIS COMPLAINT IS BEING REPORTED DUE TO THE FOLLOWING CONCLUSION: THE PATIENT CLAIMED THAT SHE DEVELOPED ELEVATED BG LEVELS WITH SYMPTOMS SUGGESTIVE OF SEVERE HYPERGLYCEMIA. HOWEVER, AT THIS TIME, IT IS UNKNOWN IF THE PUMP, USE-ERROR, AND/OR DIABETES MANAGEMENT FACTORS CONTRIBUTED TO THE PATIENT'S INJURIES.

    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 57 YR Life Threatening