BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4260254 · Received November 18, 2014

    Report

    Report Number
    2032227-2014-53895
    Event Type
    Malfunction
    Date Received
    November 18, 2014
    Date of Event
    October 18, 2014
    Report Date
    October 21, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    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. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Additional Manufacturer Narrative · 1

    NO UNEXPECTED AUDIO/BEEP ANOMALIES NOTED DURING TESTING. INSULIN PUMP VIBRATED DURING SELF TEST, TWO NORMAL VIBRATIONS NOTED. INSULIN PUMP PASSED DISPLACEMENT TEST AND SELF TEST. ALL BUTTONS FUNCTIONED PROPERLY. HOWEVER, INSULIN PUMP HAD MOISTURE DAMAGE ON KEYPAD TRACES NOTED DURING VISUAL INSPECTION. INSULIN PUMP HAD A CRACKED CASE AT LCD WINDOW CORNERS NOTED, CRACKED LCD WINDOW, CRACKED RESERVOIR TUBE LIP, SCRATCHES ON RESERVOIR TUBE WINDOW, CRACKED BATTERY TUBE THREADS AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER'S INSULIN PUMP WAS BEEPING FOR LONG PERIODS OF TIME. THE CUSTOMER'S BLOOD GLUCOSE LEVEL WAS 196 MG/DL. HER KEYPAD WAS UNRESPONSIVE AND THE INSULIN PUMP HAD A CRACK JUST OUTSIDE THE SCREEN. SHE WAS ADVISED TO DISCONNECT FROM THE INSULIN PUMP AND REVERT TO BACK UP PLAN. THE PRODUCT WAS RETURNED. NOTHING FURTHER TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    746329 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR