BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2193360 · Received July 29, 2011

    Report

    Report Number
    2032227-2011-01859
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 14, 2011
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE READING OF 34 MG/DL. AFTER BEING TREATED, THE CUSTOMER'S BLOOD GLUCOSE READING WAS 324 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP AND SENSOR WERE EXPOSED TO (B)(6) SCANNERS. SINCE BEING EXPOSED, THE INSULIN PUMP HAS BEEN ACTING STRANGELY. TROUBLESHOOTING WAS PERFORMED. THE INSULIN PUMP PASSED THE DISPLACEMENT AND SELF TESTS. THE INSULIN PUMP WAS ABLE TO REWIND AND PRIME. THE CUSTOMER DID NOT FEEL COMFORTABLE WITH THE INSULIN PUMP, AND REQUESTED A REPLACEMENT. 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-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization (B)(4) QUICK-SET PARADIGM INSULIN INFUSION SET:| MMT-397