BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3133966 · Received May 29, 2013

    Report

    Report Number
    2032227-2013-02188
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 24, 2013
    Report Date
    May 9, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP RECEIVED WITH PRIME ALARMS DURING BASIC OCCLUSION TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PRIME DURING PRIME TEST DUE TO PROTRUDED/LOOSE DRIVE SUPPORT DISK. UNABLE TO PERFORM OCCLUSION TEST DUE TO PRIME ALARM. THE INSULIN PUMP HAD A MISSING END CAP STICKER. THE INSULIN PUMP WAS RECEIVED WITHOUT THE BELT CLIP, UNABLE TO VERIFY BELT CLIP ANOMALY. NO PHYSICAL DAMAGE TO BELT CLIP SLOT NOTED.

    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

    CUSTOMER REPORTED THAT SHE WAS HOSPITALIZED DUE TO HIGH BLOOD GLUCOSE AND KIDNEY INFECTION. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF HOSPITALIZATION WAS 327 MG/DL. CUSTOMER STATED THAT THE INSULIN PUMP WAS ALARMING AND SQUIRTING THE INSULIN OUT DURING THE MANUAL PRIME. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234656 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523RNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization