BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2202497 · Received August 5, 2011

    Report

    Report Number
    3004209178-2011-82442
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 17, 2011
    Report Date
    July 17, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS REVEALED THAT THE INSULIN PUMP WAS RECEIVED WITH A BUTTON ERROR ALARM AS A RESULT OF CORRODED KEYPAD TRACES. ALSO THE KEYPAD OVERLAY HAD WEAK ADHESIVE BOND AT SEVERAL LOCATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP ALARMED BUTTON ERROR. TROUBLESHOOTING WAS PERFORMED, AND THE CUSTOMER WAS NOT ABLE TO CLEAR THE ALARM. ADVISED THE CUSTOMER TO DISCONTINUE USE OF THE INSULIN PUMP AND REVERT TO BACK UP PLAN. DURING THE CALL, THE CUSTOMER MENTIONED THAT HER RECERTIFIED INSULIN PUMP DID MALFUNCTION AND SHE HAD TO GO TO THE HOSPITAL. ATTEMPTED TO CALL THE CUSTOMER TO GET MORE INFO REGARDING HER ADMISSION, AND HER HUSBAND STATED THAT SHE WENT TO THE HOSPITAL OVER A YEAR AGO DUE TO HER INSULIN PUMP MALFUNCTIONING, BUT THE CUSTOMER DID NOT RECEIVE A MEDICAL TREATMENT. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization