BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 1812289 · Received August 20, 2010

    Report

    Report Number
    3004209178-2010-82577
    Event Type
    Injury
    Date Received
    August 20, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 6, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 INCLUDING THE DISPLACEMENT TEST. THE DEVICE WAS PROGRAMMED WITH MULTIPLE BASALS AND BOLUSES AND MONITORED. ALL BASALS AND BOLUSES WERE DELIVERED COMPLETELY THEIR INDICATED AMOUNTS AND WERE PROPERLY RECORDED IN THE BASAL AND BOLUS HISTORY RESPECTIVELY. AFTER TESTING, IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS NOT FUNCTIONING. THE CUSTOMER STATED THAT THE DAY BEFORE SHE HAD A LOW BLOOD GLUCOSE OF 63MG/DL. THE CUSTOMER STATED THAT SHE SUSPENDED THE DEVICE AND IN LESS THAN ONE HOUR, SHE HAD TO CALL THE PARAMEDICS. THE CUSTOMER STATED THAT THE DEVICE DID NOT STOP AND IT CONTINUED GIVING HER INSULIN. TROUBLESHOOTING WAS PERFORMED. CHECKED THE ALARM HISTORY AND IT REVEALED A NO DELIVERY ALARM. TIME AND DATE WERE CORRECT. NO FURTHER INFORMATION WAS PROVIDED.

    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 PUERTO RICO OPERATIONS MED-REL MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention