BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAB PRDGM INS V2.2 BL EN

    MDR report key: 1142782 · Received August 27, 2008

    Report

    Report Number
    2032227-2008-01477
    Event Type
    Injury
    Date Received
    August 27, 2008
    Date of Event
    August 15, 2008
    Report Date
    August 16, 2008
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT SHE WAS HOSPITALIZED DUE TO HYPERGLYCEMIA. THE CUSTOMER STATED THAT THE INSULIN PUMP RAN OUT OF INSULIN WITHOUT NOTIFYING HER, RESULTING IN THE EVENT. TROUBLESHOOTING WAS PERFORMED, AND IT WAS FOUND THAT THE INSULIN PUMP HAD ALARMED LOW RESERVOIR SEVERAL TIMES PRIOR TO THE EVENT. THE INSULIN PUMP PASSED THE PRIME TEST. HOWEVER, THE HIGH PRESSURE TEST COULD NOT BE PERFORMED BECAUSE THE CUSTOMER DID NOT HAVE A TUBING CLAMP AT THE TIME OF THE PHONE CALL. THE INSULIN PUMP WAS PROGRAMMED CORRECTLY. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAB PRDGM INS V2.2 BL EN INFUSION PUMP LZG MEDTRONIC MINIMED MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization