BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 3090245 · Received May 2, 2013

    Report

    Report Number
    2531779-2013-05797
    Event Type
    Injury
    Date Received
    May 2, 2013
    Report Date
    April 3, 2013
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    FOLLOW-UP #1 DATE OF SUBMISSION (B)(4) 2013 DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED AND EVALUATED BY PRODUCT ANALYSIS ON (B)(4) 2013 WITH THE FOLLOWING FINDINGS: A REVIEW OF THE TOTAL DAILY DOSE HISTORY SHOWED THAT THE DAILY INSULIN DELIVERY TOTALS WERE FOUND TO BE WITHIN SPECIFICATION. A REVIEW OF THE BLACK BOX AND PUMP ALARM HISTORY INDICATED TYPICAL USAGE ALARMS AND WARNINGS. IT WAS NOTED IN PUMP HISTORY THE LAST BOLUS AND BASAL DELIVERY WAS ON (B)(4) 2013. THE REWIND, PRIME AND LOAD STEPS WERE SUCCESSFULLY PERFORMED ON THE PUMP. A 10 UNIT NORMAL BOLUS AND A 10 UNIT AUDIO BOLUS WERE SUCCESSFULLY PERFORMED ON THE PUMP AND WERE ACCURATELY RECORDED IN PUMP HISTORY. THE 24 HOUR BASAL TEST WAS SUCCESSFULLY EXECUTED ON THE PUMP. THE 29 HOUR FLOW ACCURACY TEST WAS PERFORMED AND THE PUMP WAS FOUND TO BE DELIVERING WITHIN SPECIFICATIONS. THE FORCE SENSOR WAS FOUND TO BE WITHIN CALIBRATION DURING A CALIBRATION CHECK. NO DEFECTS WERE FOUND WITH PUMP AND NO DELIVERY ISSUES WERE NOTED WITH THE PUMP.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PATIENT CONTACTED ANIMAS STATING DURING THE NIGHT HE EXPERIENCED BLOOD GLUCOSE (BG) VALUES IN THE 18MMOL/L TO "HIGH" RANGE WITH MODERATE THIRST. THE PATIENT REPORTEDLY TREATED THE HIGH BGS BASED ON THE FOLLOWING PROTOCOL: THE PATIENT REPORTEDLY BOLUSED BY THE PUMP AND WOULD MONITOR HIS BGS; IF BGS WERE STILL ELEVATED THAN HE WOULD TREAT VIA CORRECTION INJECTION. THE PATIENT REPORTEDLY HAS RETINOPATHY, NEPHROPATHY, HAS 30 TO 35% OF A FUNCTIONING KIDNEY AND WAS TAKING BLOOD PRESSURE MEDICATION AND ASPIRIN. THE PATIENT REPORTEDLY NOTICED HIS BGS RAN HIGHER THAN NORMAL AND THAT THE BGS SPIKED IN THE EVENINGS. THE ISSUE REPORTEDLY OCCURRED FOR 2 TO 3 WEEKS. THE PATIENT DENIED HAVING ANY SITE/SET OR CARTRIDGE ISSUES. CUSTOMER SUPPORT (CS) REVIEWED THE PUMP WITH THE PATIENT AND THERE WERE NO PROGRAMMING/SETTINGS ISSUES NOTED WITH THE PUMP. THE TOTAL DAILY DOSE REPORTEDLY WAS FOUND TO BE CORRECT AND ACCURATELY RECORDED IN PUMP HISTORY. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT EXPERIENCED A HYPERGLYCEMIC EVENT WHILE USING INSULIN PUMP THERAPY. THE PATIENT REPORTEDLY ACTIVATED DIFFERENT BASAL PROGRAMS DEPENDING ON HIS WORK SHIFT. THERE WAS NO INDICATION OF PUMP MALFUNCTION OR A DELIVERY ISSUE WITH THE PUMP OR THAT THE PUMP WAS A CONTRIBUTING FACTOR TO THE PATIENT'S BG EXCURSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191434 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Life Threatening