BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183051 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-39999
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED WITH A CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHES ON THE DISPLAY WINDOW AND A SCRATCHED RESERVOIR TUBE WINDOW. THE VISUAL INSPECTION SHOWED THAT THE DAMAGE TO THE LCD SCREEN WAS A SCRATCH AND NOT A CRACK AS REPORTED.

    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4)

    Description of Event or Problem · 1

    CUSTOMER REPORTED THERE WAS A CRACK ON HIS INSULIN PUMP'S SCREEN. HE STATED THE CRACK WAS AT THE RIGHT CORNER OF HIS SCREEN. THE CUSTOMER'S BLOOD GLUCOSE WAS UNKNOWN. HE WAS UNAWARE OF HOW THE DAMAGE HAD OCCURRED. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO A BACK-UP PLAN. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661935 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR