BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 2970513 · Received February 20, 2013

    Report

    Report Number
    3004209178-2013-91160
    Event Type
    Injury
    Date Received
    February 20, 2013
    Date of Event
    February 2, 2013
    Report Date
    February 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH BLANK DISPLAY WHEN BUTTON PRESSED. ANOMALY ISOLATED TO THE LCD BOARD. UNABLE TO PERFORM BASIC OCCLUSION TEST, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST DUE TO BLANK DISPLAY ANOMALY.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BEING HOSPITALIZED FOR A NON DIABETES RELATED ISSUE. THE CUSTOMER STATED THAT THE INSULIN PUMP ALARMED. REVIEWED THE ALARM HISTORY AND FOUND A LOW RESERVOIR ALARM. DAYS LATER, HIS WIFE CALLED TO REPORT THAT THE INSULIN PUMP HAD INTERMITTENT BLANK DISPLAY. THE CALLER STATED THAT THE CUSTOMER HAD A STROKE AND HE WAS ADMITTED, BUT THEY DO NOT BELIEVE THE INSULIN PUMP CAUSED THE EVENT. TROUBLESHOOTING WAS PERFORMED. THE BLOOD GLUCOSE READING WAS 94MG/DL. THE CUSTOMER STATED THAT THE BUTTONS WERE UNRESPONSIVE, AND WHEN THEY PRESSED THE BUTTONS THE DISPLAY GOES BLANK AND TAKES A MINUTE TO COME BACK. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75004 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-722NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization