BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4163541 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36413
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    August 3, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. THE INSULIN PUMP PASSED OFF NO POWER TEST, SELF-TEST, UNEXPECTED RESTART ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, AND EXCESSIVE NO DELIVERY ALARM TEST. THE DEVICE WAS UNABLE TO PRIME DURING PRIME TEST DUE TO FAULTY FORCE SENSOR RESISTOR. FUNCTIONAL TESTING WAS NOT COMPLETED DUE TO PRIME ANOMALY. ALL OF THE BUTTONS FUNCTIONED PROPERLY. NO DAMAGE ON KEYPAD TRACES NOTED DURING VISUAL INSPECTION AND NO BUTTON ERROR ALARM NOTED. LCD CONNECTOR WAS INSPECTED AND NO ANOMALY WAS NOTED. THE DEVICE HAD MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, CRACKED BELT CLIP SLOT, AND CRACKED BATTERY TUBE THREADS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 RECENTLY BEING HOSPITALIZED WITH A BLOOD GLUCOSE LEVEL OF 828 MG/DL AT THE TIME OF ADMISSION. CUSTOMER REPORTED HAVING A SKIN INFECTION THAT SPREAD TO HIS LUNGS. REVIEW OF THE ALARM HISTORY SHOWED THAT THE INSULIN PUMP HAD RECENTLY RETURNED A BUTTON ERROR ALARM. BLOOD GLUCOSE LEVEL AT THE TIME OF THE CALL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639117 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LCAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization