BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4150013 · Received October 7, 2014

    Report

    Report Number
    2032227-2014-34803
    Event Type
    Malfunction
    Date Received
    October 7, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME TEST, AND EXCESSIVE NO DELIVERY ALARM TEST. NO EXCESSIVE NO DELIVERY ALARM WAS NOTED. THE INSULIN PUMP HAD A CRACKED CASE AT A DISPLAY WINDOW CORNER, MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED BELT CLIP SLOT AT THE BATTERY TUBE THREADS AREA AND A CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER'S DOCTOR REPORTED THAT CUSTOMER'S INSULIN PUMP HAS BEEN HAVING ISSUES WITH NO DELIVERY ALARMS FOR THE PAST FEW DAYS. CUSTOMER'S BLOOD GLUCOSE WAS 396 MG/DL. CUSTOMER'S DOCTOR DECLINE TROUBLESHOOTING AND WANTS A CONTINUING THERAPY INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626813 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR