BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2863293 · Received December 10, 2012

    Report

    Report Number
    3004209178-2012-91178
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 23, 2012
    Report Date
    November 23, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PATIENT

    Narratives

    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. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    UNABLE TO PRIME DURING PRIME ALARM TEST DUE TO FAULTY FORCE SENSOR. UNABLE TO PERFORM OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. THE INSULIN PUMP PASSED THE BASIC OCCLUSION AND DISPLACEMENT TEST. CRACKED RESERVOIR WINDOW, SCRATCHED DISPLAY AND CASE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE EXPERIENCED UNEXPLAINED LOW BLOOD GLUCOSE OF 40MG/DL AND THE PARAMEDICS WERE CALLED. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE WAS 70MG/DL, BUT IT KEPT DROPPING. TROUBLESHOOTING WAS PERFORMED. THE PROGRAMMING ON THE DEVICE WAS CORRECT. DURING THE CALL, IT WAS MENTIONED THAT THE INSULIN PUMP DELIVERED LARGE AMOUNT OF INSULIN ON ITS OWN, WHICH CAUSED HER BLOOD GLUCOSE TO DROP. THE CALLER STATED THAT THE RESERVOIR WAS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. ASSISTED THE CUSTOMER TO RUN A DISPLACEMENT TEST AND THE TEST FAILED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention