BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2905091 · Received January 9, 2013

    Report

    Report Number
    2032227-2013-00086
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    October 23, 2012
    Report Date
    December 18, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTS INCLUDING PRIME, DISPLACEMENT, BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST. NO BUTTON ERROR ALARMS NOTED. HOWEVER, CORRODED KEYPAD TRACES NOTED DURING VISUAL INSPECTION. NO WEAK BATTERY ALARMS NOTED. MISSING END CAP STICKER, CRACKED RESERVOIR TUBE LIP AND SCRATCHED DISPLAY WINDOW NOTED DURING VISUAL INSPECTION. NO UNEXPECTED WEAK BATTERY ALARMS NOTED. NO MOTOR ERROR ALARMS NOTED. HOWEVER, MOISTURE DAMAGE WAS NOTED ON MOTOR ASSEMBLY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE WAS TAKEN TO THE EMERGENCY ROOM DUE TO BLOOD GLUCOSE LEVELS GREATER THAN 600 MG/DL. THE CUSTOMER STATED THAT HER BLOOD GLUCOSE LEVELS JUST KEPT RISING PRIOR TO THE EVENT. THE CUSTOMER ALSO REPORTED WEAK BATTERY, BUTTON ERROR AND MULTIPLE MOTOR ERROR ALARMS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10482 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Hospitalization