BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 3791277 · Received May 5, 2014

    Report

    Report Number
    3004209178-2014-84293
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    April 21, 2014
    Report Date
    April 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS RECEIVED IN WITH A CRACKED RESERVOIR TUBE LIP. NO ANOMALY WAS NOTED WITH THE DRIVE SUPPORT CAP DURING VISUAL INSPECTION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DRIVE SUPPORT CAP WAS INDENTED MORE THAN IT WAS WHEN HE FIRST GOT THE INSULIN PUMP. THE BLOOD GLUCOSE READING WAS 170MG/DL. THE CUSTOMER STATED THAT THE DEVICE MAY HAVE BEEN BUMPED, AND THE DRIVE SUPPORT CAP WAS PUSHED IN A LITTLE MORE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268393 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR