BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAS PRDGM INS V2.2 SK EN

    MDR report key: 1810123 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-82487
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    July 1, 2010
    Report Date
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    LZG
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    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. WE, THEREFORE, CONSIDER THIS REPORT COMPLETE TO THE BEST OF OUR KNOWLEDGE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED HAVING HIGH AND LOW BLOOD GLUCOSE. THE CUSTOMER STATED THAT HE FELL AND BROKE HIS WRIST/ARM DUE TO A LOW BLOOD GLUCOSE INCIDENT. A FOLLOWUP REPORT ON THE EVENT WAS CONDUCTED AND A FEW DAYS LATER THE CUSTOMER STATED THAT HE DOES NOT REMEMBER WHAT IT HAPPENED OR WHY HIS GLUCOSE LEVEL DROPPED AND HAD THE ACCIDENT. THE CUSTOMER STATED THAT HIS SISTER TOOK HIM TO THE EMERGENCY ROOM. THE BLOOD GLUCOSE READING WAS 50 MG/DL. THE CUSTOMER STATED THAT THE INSULIN PUMP WAS NOT THE PROBLEM, BUT THE PROGRAMMING SETTINGS NEED TO BE ADJUSTED. THE CUSTOMER ALSO MENTIONED THAT THE VOLUME ON THE DEVICE WAS TOO LOW AND HE HAD DIFFICULTY HEARING THE ALARMS. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAS PRDGM INS V2.2 SK EN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization