BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANIMAS INSULIN INFUSION PUMP

    MDR report key: 2023870 · Received February 14, 2011

    Report

    Report Number
    2531779-2011-00865
    Event Type
    Malfunction
    Date Received
    February 14, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 15, 2011
    Manufacturer
    ANIMAS CORP.
    Product Code
    LZG
    PMA / PMN Number
    K042873
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO ANIMAS FOR EVAL. IF THE DEVICE IS RETURNED, AN EVAL WILL BE CONDUCTED AND THE RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1: 06/08/2016. DEVICE EVALUATION: THE PUMP HAS BEEN RETURNED TO ANIMAS AND EVALUATED ON 06/02/2016 WITH THE FOLLOWING FINDINGS: THE PUMP¿S BLACK BOX DATA FROM THE DATE OF THE ALLEGED EVENT HAD BEEN OVERWRITTEN DUE TO CONTINUED USE OF THE PUMP. THE DATE IN THE CURRENT BLACK BOX SHOWED NO ISSUES WITH INSULIN DELIVERY OR VARIANCES BETWEEN THE AMOUNT DELIVERED AND THE EXPECTED AMOUNT. THE PUMP PERFORMED THE PRIME STEPS WITH NO ISSUES. THE PUMP PASSED A DELIVERY ACCURACY TEST AND WAS FOUND TO BE DELIVERING WITHIN THE REQUIRED RANGE.

    Description of Event or Problem · 1

    THE PT'S HUSBAND REPORTED THAT HE CAME HOME TO FIND THE PT ON THE FLOOR. SHE WAS AWAKE AND SHE REPORTEDLY HAD HIT HER HEAD AND COULD NOT GET UP. HE CHECKED HER BLOOD GLUCOSE LEVEL AT THE TIME AND STATED THAT IT WAS 56 MG/DL. HE REPORTEDLY GAVE THE PT SOME FOOD AND NO OTHER MEDICAL INTERVENTION OR ATTENTION WERE SOUGHT. HE REPORTS THAT THE PT SAW AN HCP THE WEEK PRIOR TO FALLING. THROUGH TROUBLESHOOTING, THERE WERE NO INSULIN LEAKS OR BUBBLES AND THE TOTAL DAILY DOSES MATCHED THE SET BASAL RATES. THERE IS NO EVIDENCE OF A PUMP MALFUNCTION ALTHOUGH THE REPORTER AGREED TO CONTACT AN HCP REGARDING TREATMENT FOR THE ELEVATED BLOOD GLUCOSE LEVELS AND TO DISCUSS POSSIBLE SITE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANIMAS INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG ANIMAS CORP. ANIMAS 2020 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Life Threatening| R