BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4183080 · Received October 17, 2014

    Report

    Report Number
    2032227-2014-40058
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. HOWEVER, THE PUMP HAD A CRACKED RESERVOIR TUBE LIP AND MINOR SCRATCHES ON THE LCD WINDOW.

    Additional Manufacturer Narrative · 1

    (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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THEIR BLOOD GLUCOSE READINGS HAVE BEEN HIGH LATELY DUE TO BEING SICK. CUSTOMER STATED THAT HIS BLOOD GLUCOSE READING WAS 457 MG/DL AND HAS TREATED WITH THE INSULIN PUMP. CUSTOMER STATED THAT THE INSULIN PUMP WENT INTO THRESHOLD SUSPEND AND MADE A SHORT SOUND AND THEN WENT TO VIBRATE. CUSTOMER MENTIONED THAT NOTIFICATION CHANGES SOMETIMES FROM ONE TONE TO TWO TONES. CUSTOMER'S BLOOD GLUCOSE READING AT THE TIME OF THE CALL WAS 297 MG/DL. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    660478 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR