BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 3974010 · Received August 1, 2014

    Report

    Report Number
    3004209178-2014-89013
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT
    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE INSULIN PUMP BECAME CRACKED. THE BLOOD GLUCOSE READING WAS 208 MG/DL. CUSTOMER REPORTED THAT THE PHYSICAL DAMAGE OCCURRED DUE TO BUMPING THE INSULIN PUMP FREQUENTLY AND THAT SHE FOUND THE BATTERY CAP HAD BEEN OVERTIGHTENED. CUSTOMER ALSO REPORTED A HOSPITALIZATION 9 MONTHS PRIOR. SHE ONLY RECALLED THAT SHE WAS DEHYDRATED AND IN A LOT OF PAIN AND DID NOT THINK THAT THE INSULIN PUMP WAS THE CAUSE OF THE HIGH BLOOD GLUCOSE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450594 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization