BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212977 · Received August 8, 2011

    Report

    Report Number
    2032227-2011-01985
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 26, 2011
    Report Date
    July 26, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE LEVELS. THE REPORTED BLOOD GLUCOSE READING WAS 500 MG/DL. THE CALLER STATED THAT THE INSULIN PUMP DIDN'T APPEAR TO BE DELIVERING INSULIN THE WAY IT WAS SUPPOSED TO. THE CUSTOMER WAS ADVISED TO DISCONTINUE USING THE INSULIN PUMP, BUT HE CONTINUED USING IT. THE CALLER ALSO STATED THAT THE CUSTOMER DID NOT RECEIVE ANY NO DELIVERY ALARMS. TROUBLESHOOTING WAS PERFORMED. ONLY LOW RESERVOIR AND LOW BATTERY ALARMS WERE FOUND IN THE ALARM HISTORY. THE INSULIN PUMP DID NOT PASS THE PRIME TEST. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization