BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3982110 · Received August 5, 2014

    Report

    Report Number
    3004209178-2014-90111
    Event Type
    Malfunction
    Date Received
    August 5, 2014
    Date of Event
    July 5, 2014
    Report Date
    July 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Report Source
    Manufacturer report
    Reporter Location
    MA
    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 HAD BLANK DISPLAY DUE TO BROKEN SOLDER JOINT AND LIFTED TRACES ON THE INTERFACE BOARD. THE DEVICE HAD BROKEN BELT CLIP SLOT, CRACKED RESERVOIR TUBE, CRACKED BATTERY TUBE THREADS, MINOR SCRATCHED DISPLAY WINDOW. THE UNIT WAS RECEIVED WITHOUT BELT CLIP. UNABLE TO VERIFY DAMAGE TO BELT CLIP.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT THE INSULIN PUMP ISN'T TURNING ON. THE INSULIN PUMP WAS DROPPED WHEN THE CUSTOMER'S BELT CLIP BROKE. BLOOD GLUCOSE READING AT THE TIME WAS 120 MG/DL. THE INSULIN PUMP HAS PHYSICAL DAMAGE IN THE FORM OF CRACKS FROM WEAR AND TEAR. THESE CRACKS WERE PRESENT PRIOR TO THE INSULIN PUMP BEING DROPPED. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WILL BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456814 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-723NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR