BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4210789 · Received October 13, 2014

    Report

    Report Number
    2032227-2014-37276
    Event Type
    Malfunction
    Date Received
    October 13, 2014
    Date of Event
    September 13, 2014
    Report Date
    September 13, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED DISPLACEMENT TEST AND REWIND TEST. MOTOR ERROR ALARMED DURING BASIC OCCLUSION TEST AND PRIME ALARMED DURING PRIME TEST, DUE TO LOOSE AND SLANTED DRIVE SUPPORT DISK NOTED. NO MOISTURE DAMAGED NOTED ON ELECTRONIC ASSEMBLY OR ON MOTOR DURING VISUAL INSPECTION. NO BELT CLIP RECEIVED. INSULIN PUMP HAD A CRACKED BELT CLIP SLOT NOTED, MINOR SCRATCHES ON LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN ALARM FOR A LOOSE DRIVE SUPPORT CAP WHILE CHANGING THE SET. THE BLOOD GLUCOSE READING WAS 273 MG/DL. CUSTOMER TREATED WITH MANUAL INJECTION. HE STATED THAT THE INSULIN PUMP HAD BEEN EXPOSED TO MOISTURE TWO TO THREE MONTHS PRIOR TO THE ISSUE. HE STATED THAT THE DRIVE SUPPORT CAP APPEARED NORMAL. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648967 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR