BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4160212 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26197
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, BASIC OCCLUSION, AND OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM, DISPLACEMENT TEST AND MOTOR TEST. NO MOTOR ERROR ALARMS NOTED. UNIT RECEIVED WITH CRACKED CASE AT DISPLAY WINDOW CORNERS, MINOR SCRATCHED DISPLAY WINDOW. UNIT RECEIVED WITH CORRODED BATTERY TUBE.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS REPORTED BY THE PT THAT THEIR INSULIN PUMP IS GIVING EXCESSIVE NO DELIVERY ALARMS. THE PT'S BLOOD GLUCOSE LEVEL IS 72 MG/DL. TROUBLE SHOOTING WAS CONDUCTED. DEVICE IS BEING RETURNED. NO FURTHER INFO AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581330 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR