BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2822240 · Received November 7, 2012

    Report

    Report Number
    2032227-2012-07674
    Event Type
    Injury
    Date Received
    November 7, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED ALL FUNCTIONAL TESTING, INCLUDING THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND NO DELIVERY TESTS. THE INSULIN PUMP WAS RECEIVED WITH INTERMITTENT BUTTON RESPONSE DUE TO CORRODED KEYPAD TRACES. NO BUTTON ERROR ALARM NOTED.

    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

    THE CUSTOMER CALLED TO REPORT A BUTTON ERROR ALARM. DURING THE CALL, THE CUSTOMER MENTIONED THAT HE WAS SWEATING HEAVILY, AND DIDN'T KNOW WHAT HIS BLOOD GLUCOSE READING WAS. ADVISED THE CUSTOMER THAT THE PARAMEDICS WOULD BE CALLED DUE TO HIS SYMPTOMS OF LOW BLOOD GLUCOSE LEVELS. ADVISED THE CUSTOMER THAT THE INSULIN PUMP WOULD BE REPLACED DUE TO GETTING A BUTTON ERROR ALARM WITHOUT PRESSING ANY BUTTONS FOR THREE MINUTES OR MORE. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC OYC MEDTRONIC MINIMED MMT-522LNAH

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention