BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 3160734 · Received June 10, 2013

    Report

    Report Number
    3004209178-2013-94615
    Event Type
    Injury
    Date Received
    June 10, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 27, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS
    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 AS NO PRODUCT HAS BEEN RETURNED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING A BUTTON ERROR. THE CUSTOMER STATED THAT HIS BLOOD GLUCOSE WENT FROM OVER 200 TO 20MG/DL, AND HE WAS DRINKING SWEET TEA. THE CUSTOMER STATED THAT SHE PASSED OUT ON (B)(6), 2013 WHILE HE WAS CHASING HIS DOG AROUND A BUILDING. BY THE TIME HE CARRIED BACK THE DOG TO HIS CAR, HE WAS FEELING TIRED AND PASSED OUT. THEN HE WOKE UP WITH AN INSULIN FLUIDS RUNNING IN HIM. THE CUSTOMER STATED THAT THE AMBULANCE CAME AND GAVE HIM AN INSULIN DRIP, BUT HE DID NOT ALLOW THEM TO TAKEN HIM TO THE HOSPITAL. THE CALLER STATED THAT HE BELIEVES THERE IS NOTHING WRONG WITH THE INSULIN PUMP, AND IT COULD BE THAT HE IS NOT EATING PROPERLY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260683 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention