BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2212980 · Received August 8, 2011

    Report

    Report Number
    2032227-2011-01988
    Event Type
    Injury
    Date Received
    August 8, 2011
    Date of Event
    July 25, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. 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 DIABETIC KETOACIDOSIS, WITH A BLOOD GLUCOSE READING OF 1250 MG/DL. PRIOR TO THE EVENT, THE CUSTOMER WAS NOT CHECKING HIS BLOOD GLUCOSE LEVELS VERY OFTEN, AND HE HAD NOT COMPLETED THE MANUAL PRIME WHEN HE CHANGED THE INFUSION SET. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. HOWEVER, THE DAILY TOTALS DID NOT MATCH WITH THE BOLUS AND BASAL RATE DELIVERY TOTALS. ALSO, IT WAS REPORTED THAT THE CUSTOMER WAS HAVING PROBLEMS WITH THE QUICK RELEASE PORTION OF THE INFUSION SET, WHICH MAY HAVE CONTRIBUTED TO THE EVENT. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO THE DISCREPANCY WITH THE DAILY TOTALS. 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-722LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization UNOMEDICAL QUICK-SET PARADIGM INSULIN INFUSION SET| MMT-396, LOT 2209461