BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP MMT-722NAP PRDGM INS V2.2 PL EN

    MDR report key: 1911777 · Received November 24, 2010

    Report

    Report Number
    3004209178-2010-83434
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 8, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS MED-REL
    Product Code
    MDS
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, 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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER STATED THAT HE WENT TO THE HOSPITAL AND GOT CHECKED FOR SCAR TISSUE. THE CUSTOMER STATED THAT IT TOOK LONG TIME TO ABSORB THE INSULIN, WHEN HE GAVE HIMSELF A CORRECTION. THE CUSTOMER ALSO REPORTED THAT HE WAS HOSPITALIZED AND HIS BLOOD GLUCOSE READING WAS 563MG/DL. THE CUSTOMER STATED THAT HE CHANGES THE INFUSION SET EVERY THREE DAYS. THE SETTINGS ON THE INSULIN PUMP WERE CORRECT. THE CUSTOMER ALSO STATED THAT THE DISPLAY WINDOW IS SCRATCHED AND HE IS HAVING HARD TIME TO SEE THE NUMBERS ON THE SCREEN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP MMT-722NAP PRDGM INS V2.2 PL EN INFUSION PUMP MDS MEDTRONIC PUERTO RICO OPERATIONS MED-REL MMT-722NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization