BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4142329 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33693
    Event Type
    Malfunction
    Date Received
    October 5, 2014
    Date of Event
    August 15, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC (B)(4). 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP WAS PROGRAMMED WITH 2.0 UNITS BOLUS AND MONITORED. THE BOLUS WAS DELIVERED AND RECORDED PROPERLY IN BOLUS HISTORY SCREEN. NO MEMORY ANOMALY NOTED. INSULIN PUMP WAS UNABLE TO DOWN LOAD HISTORY FILE USING CARELINK PRO DUE TO ALARM FOUND IN ALARM HISTORY SCREEN. SOFTWARE ALARM DUE TO CORRUPTED HISTORY FILE. NO COSMETIC DAMAGE NOTED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A BOLUS THAT WAS ADMINISTERED WAS NOT APPEARING IN THE INSULIN PUMP'S BOLUS HISTORY. CUSTOMER REPORTED THAT THIS WAS A RECURRING ISSUE. BLOOD GLUCOSE LEVEL WAS NOT PROVIDED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621917 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAL

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR