BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3121501 · Received May 21, 2013

    Report

    Report Number
    2531779-2013-06780
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: A REVIEW OF THE TOTAL DAILY DOSE HISTORY INDICATED THAT INSULIN DELIVERY TOTALS REFLECTED THE USER¿S PROGRAMMED VALUES. THE PUMP WAS EXERCISED FOR 24 HOURS WITH NO DELIVERY ISSUES. THE PUMP WAS EVALUATED AND FOUND TO BE OPERATING WITHIN REQUIRED SPECIFICATIONS AND DELIVERING INSULIN ACCURATELY. EVALUATION REVEALED THE FORCE SENSOR TO BE CALIBRATED WITHIN REQUIREMENTS. THE PUMP WAS OPENED FOR INVESTIGATION AND DID NOT REVEAL ANY EVIDENCE OF DAMAGE, DEFECT OR CONTAMINATION. THIS REPORT IS MADE UNDER THE REQUIREMENTS OF THE MEDICAL DEVICE REPORTING REGULATIONS AND DOES NOT CONSTITUTE AN ADMISSION ON THE PART OF ANIMAS OF ANY DEFICIENCY IN THE PERFORMANCE OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    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. THE PUMP HAS BEEN RETURNED TO ANIMAS BUT EVALUATION HAS NOT YET BEEN COMPLETED. WHEN EVALUATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSION CAN BE MADE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT CONTACTED ANIMAS ON (B)(6) 2013, ALLEGING THAT WHILE ON A BACKUP PLAN DUE TO A PUMP MALFUNCTION, HE EXPERIENCED ELEVATED BG OF 500 MG/DL WITH DIFFICULTY THINKING TWO HOURS AFTER EATING BREAKFAST. THE PATIENT REPORTED THAT HE CALLED A FAMILY MEMBER FOR ASSISTANCE. THE PATIENT STATED THAT HE ALSO CONTACTED HIS HEALTHCARE PROVIDER (HCP) FOR RECOMMENDATIONS. THE PATIENT REPORTED THAT ON (B)(6) 2013, THE METER READING WAS ¿HI¿ AND HE WENT TO THE EMERGENCY ROOM FOR TREATMENT AND WAS SUBSEQUENTLY ADMITTED TO THE HOSPITAL. DURING HOSPITALIZATION, THE PATIENT REPORTED THAT HE WAS TREATED WITH IV INSULIN BUT DID NOT KNOW WHAT HIS ADMITTING DIAGNOSIS WAS. DURING A FOLLOW UP CALL ON (B)(6) 2013, THE PATIENT REPORTED BEING DISCHARGED FROM THE HOSPITAL ON (B)(6) 2013, ON A BACKUP PLAN. THE PATIENT STATED THAT HE THINKS HE DID NOT TAKE ENOUGH NOVOLOG TO COVER FOR THE FOOD HE CONSUMED WHILE ON THE BACKUP PLAN AND THAT IS WHAT CAUSED HIS BG TO ELEVATE. THE PATIENT REPORTED THAT HIS BG HAS BEEN WITHIN TARGET RANGE ON THE BACKUP PLAN SINCE HOSPITAL DISCHARGE. AT THE CONCLUSION OF THE CALL, THE PATIENT REMAINED ON A BACKUP PLAN WHILE WAITING FOR A NEW PUMP. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED ELEVATED BG AND HOSPITALIZATION AS A RESULT ON INADEQUATE INSULIN DELIVERY WHILE ON A BACKUP PLAN DUE TO AN INSULIN PUMP MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224531 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR