BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4212475 · Received October 25, 2014

    Report

    Report Number
    2032227-2014-43301
    Event Type
    Injury
    Date Received
    October 25, 2014
    Date of Event
    August 22, 2014
    Report Date
    September 26, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNABLE TO PERFORM DISPLACEMENT TEST, REWIND TEST, BASIC OCCLUSION TEST, PRIME TEST, OCCLUSION TEST AND EXCESSIVE NO DELIVERY TEST DUE TO BLANK DISPLAY. INSULIN PUMP HAD A BLANK DISPLAY DUE TO SEVERELY CORRODED BATTERY TUBE AND SLIGHTLY CORRODED BATTERY CAP CONTACT. NO WARPED BATTERY TUBE NOTED. INSULIN PUMP HAD A CRACKED BATTERY TUBE THREADS CRACKED, BROKEN RESERVOIR TUBE LIP, CRACKED LCD WINDOW, CRACKED CASE AT LCD WINDOW CORNERS, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS AND STAINED END CAP STICKER.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S HAD A DAMAGED INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 555 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS HIGH BECAUSE SHE FORGOT TO BOLUS FOR HER MEAL. THE PATIENT'S WAS TREATED FOR HIGH BLOOD GLUCOSE WITH THE BOLUS FROM THE INSULIN PUMP. THE CUSTOMER'S STATED THAT THE INSULIN PUMP DAMAGED WAS THAT THE BATTERY COMPARTMENT WAS WARPED AND RESERVOIR COMPARTMENT HAD PIECES MISSING. THE TROUBLESHOOTING WAS PERFORMED. THE CUSTOMER'S WAS ADVISED TO DISCONTINUE THE USE OF THE PUMP AND REVERT TO BACK UP PLAN. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WAS GOING TO BE REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680778 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Life Threatening