BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-522NAH PRDGM INS V2.4 PK

    MDR report key: 1902365 · Received November 12, 2010

    Report

    Report Number
    3004209178-2010-83340
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 18, 2010
    Report Date
    November 2, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 LOW BLOOD GLUCOSE LAST MONTH. THE PARAMEDICS WERE CALLED FOUR TIMES, AND SHE WAS ADMITTED IN THE HOSP TWICE. THE CUSTOMER STATED THAT SHE WAS GIVEN TWO GLUCAGON SHOTS AND HER BLOOD GLUCOSE WENT DOWN TO 73MG/DL. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 187 MG/DL WHEN SHE LEFT THE HOSP. TROUBLESHOOTING WAS PERFORMED. THE SETTINGS ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER STATED THAT SHE STARTED TO TAKE A MEDICATION TWO MONTHS AGO, AND SHE NOTICED THAT HER BLOOD GLUCOSE HAVE BEEN GOING DOWN. THE CUSTOMER STATED THAT THE DOCTORS AT THE HOSP DO NOT BELIEVE IT IS THE CASE. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-522NAH PRDGM INS V2.4 PK INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-522NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention