BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2854433 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-91030
    Event Type
    Malfunction
    Date Received
    December 3, 2012
    Date of Event
    November 10, 2012
    Report Date
    November 14, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY
    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 BEING HOSPITALIZED DUE TO LOW BLOOD GLUCOSE. THE CALLER STATED THAT HER BLOOD GLUCOSE READING WAS 65MG/DL AND WHILE TREATING HER GLUCOSE LEVEL SHE FELL. TROUBLESHOOTING WAS PERFORMED. THE TIME WAS NOT CORRECT. ASSISTED THE CALLER TO CORRECT IT. THE CALLER STATED THAT THE RESERVOIR IS SHOWING THE SAME AMOUNT OF INSULIN AS SHOWN ON THE STATUS SCREEN. THE CUSTOMER RAN THE DISPLACEMENT TEST AND THE TEST FAILED. THE CALLER MENTIONED THAT A PIECE OF THE RESERVOIR COMPARTMENT CAME OFF AND THE TOP OF THE SCREEN WAS CRACKED. ADVISED THE CALLER THAT THE INSULIN PUMP WOULD BE REPLACED AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PARADIGM INSULIN INFUSION PUMP LZG LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization