BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3112530 · Received May 14, 2013

    Report

    Report Number
    2032227-2013-01950
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    April 19, 2013
    Report Date
    April 20, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE INSULIN PUMP DID HAVE CRACKED BATTERY TUBE THREADS AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS HOSPITALIZED WITH A LOW BLOOD GLUCOSE OF 40 MG/DL. THE CALLER STATED THAT THE CUSTOMER HAD BEEN FASTING AS HE WAS SCHEDULED FOR SURGERY THAT DAY. HOWEVER, THE SURGERY WAS CANCELLED BECAUSE HE DRANK A SODA. TROUBLESHOOTING WAS PERFORMED, AND THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. FOUND THAT THE CUSTOMER DELIVERED A LARGE BOLUS OF 21.35 ON THE DAY OF THE HOSPITALIZATION. THE RESERVOIR VOLUME WAS ACCURATE. THE INSULIN PUMP WAS NOT EXPOSED TO HIGH MAGNETIC FIELDS. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST. FOUND THAT THE DOME LABEL WAS MISSING. 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
    213016 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization