BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4123033 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29568
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE REWIND, DISPLACEMENT, PRIME AND EXCESSIVE NO DELIVERY TEST. NO EXCESSIVE NO DELIVERY ALARM NOTED. THE DEVICE WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED BATTERY TUBE THREADS, AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT SHE WAS EXPERIENCING HIGH BLOOD GLUCOSE AND THEN GOING LOW. BLOOD GLUCOSE WENT DOWN TO 28 MG/DL. CUSTOMER HAD MANY NO DELIVERY ALARMS. CURRENT BLOOD GLUCOSE IS 166 MG/DL. THE CUSTOMER HAS NOT TRIED DIFFERENT CANNULA LENGTHS. INSULIN IS NOT EXPIRED OR DENATURED AND SHE DOES ROTATE SITES AND AVOIDS SCAR TISSUE. CUSTOMER DECLINED TO TROUBLESHOOT FOR HIGH BLOOD GLUCOSE. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600739 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523NAP A7523NAPJ

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR