BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522LNAB PRDGM INS BL EN ML

    MDR report key: 1931173 · Received December 10, 2010

    Report

    Report Number
    2032227-2010-83396
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 23, 2010
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. NO BOLUS HISTORY ANOMALY WAS NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HE WAS TAKEN TO THE EMERGENCY ROOM BY THE PARAMEDICS AFTER EXPERIENCING AN INSULIN REACTION. THE CUSTOMER STATED THAT HE WAS UNCONSCIOUS AND HAD A BLOOD GLUCOSE READING OF 28 MG/DL. HE WAS TOLD BY THE PARAMEDIC THAT THE INSULIN PUMP WAS COUNTING UP TO 10.0, THEN BLINKED. TROUBLESHOOTING REVEALED THAT THE CUSTOMER HAD DELIVERED THREE 10 UNIT BOLUSES IN A SIX HOUR PERIOD. HOWEVER THE CUSTOMER DID NOT RECALL PROGRAMMING THEM, AND STATED THAT THERE IS NO WAY THE INSULIN PUMP BUTTONS COULD HAVE BEEN PRESSED. ADVISED THAT THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522LNAB PRDGM INS BL EN ML INFUSION PUMP MDS MEDTRONIC MINIMED MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization