BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3011730 · Received March 19, 2013

    Report

    Report Number
    2032227-2013-01086
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    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 INCLUDING THE DISPLACEMENT TEST. THE DEVICE HAD SCRATCHED DISPLAY WINDOW, CRACKED RESERVOIR TUBE AND LIP, CRACKED BATTERY THREADS, AND MISSING END CAP STICKER. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER WAS RECENTLY HOSPITALIZED FOR NON DIABETES RELATED ISSUES, BUT THE DOCTOR STATED THAT THE INSULIN PUMP WAS NOT FUNCTIONING. THE CALLER STATED THAT THE CUSTOMER'S BLOOD GLUCOSE READING WAS OVER 600MG/DL. TROUBLESHOOTING WAS PERFORMED. THE TIME AND DATE WERE INCORRECT. ASSISTED THE CALLER WITH CORRECTING THEM. IT WAS STATED THAT THE CUSTOMER WAS DISORIENTED, VOMITING, DEHYDRATED, AND COULD NOT EAT OR DRINK. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113292 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-522RNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization