BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 4141794 · Received October 4, 2014

    Report

    Report Number
    2032227-2014-32979
    Event Type
    Malfunction
    Date Received
    October 4, 2014
    Date of Event
    August 30, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO PRIME DURING THE PRIME REWIND TEST, DUE TO FAULTY FORCE SENSOR RESISTOR. NO PRIME REWIND ALARM WAS NOTED. HOWEVER, THE INSULIN PUMP HAD A CORRODED BATTERY TUBE. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED DISPLAY WINDOW CORNER, BATTERY TUBE THREADS, RESERVOIR TUBE, RESERVOIR TUBE LIP, BELT CLIP SLOT, BELT CLIP SLOT NEAR BATTERY TUBE, A SEVERELY SCRATCHED DISPLAY WINDOW AND A MISSING END CAP STICKER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT SHE RECEIVED A PRIME REWIND ALARM ON HER INSULIN PUMP. HER BLOOD GLUCOSE WAS 200 MG/DL, WHICH SHE TREATED WITH MANUAL INJECTION. DURING TROUBLESHOOTING, THE CUSTOMER STATED INSULIN WAS SQUIRTING OUT DURING THE MANUAL PRIME PROCESS. THE CUSTOMER STATED THE INSULIN PUMP MAY HAVE BEEN DROPPED AND THE DRIVE SUPPORT CAP WAS STICKING OUT. SHE WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. COSMETIC DAMAGE TO THE INSULIN PUMP HAD ALSO OCCURRED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621565 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-715LNAP

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR