BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3982317 · Received August 5, 2014

    Report

    Report Number
    2032227-2014-06168
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 6, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP PASSED DISPLACEMENT TEST, SELF TEST AND THE ERROR ALARM TEST DID NOT HAPPEN. THE DEVICE WAS MONITORED AND NO A DIFFERENT ALARM NOTED. THE UNIT WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED. HOWEVER, THE INSULIN PUMP WAS RECEIVED WITH MOISTURE DAMAGE AT THE MOTOR AND ELECTRONIC ASSEMBLY. THE UNIT WAS RECEIVED WITH MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN HAS AN UNEXPECTED RESTART. CUSTOMER STATED THE DEVICE WAS NOT STORED FOR AN EXTENDED PERIOD AND THE ALARM DID NOT OCCUR SHORTLY AFTER PUTTING A NEW BATTERY; THE BATTERY WAS CHANGED THE DAY BEFORE. CUSTOMER ALSO REPORTED THAT HE RECEIVED OTHER ALARMS DURING PRIME SEQUENCE. CUSTOMER STATED HE RECEIVED A BUTTON ERROR ALARM. CUSTOMER WAS WEARING THE DEVICE IN THE POOL AND INSULIN PUMP WAS EXPOSED TO MOISTURE BUT FLUID IS NOT VISIBLE. BLOOD GLUCOSE 277 MG/DL. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456587 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-722LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR