BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 4864263 · Received June 23, 2015

    Report

    Report Number
    3004209178-2015-68159
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    April 17, 2015
    Report Date
    June 5, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME/A33 AND NO DELIVERY TESTS. THE INSULIN PUMP WAS RECEIVED WITH CRACKED CASE AT THE DISPLAY WINDOW CORNER, MINOR SCRATCHED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER'S MOTHER REPORTED VIA PHONE CALL THAT SHE EXPERIENCED A LOW BLOOD GLUCOSE LEVEL OF 30 MG/DL. THE CUSTOMER EXPERIENCED LOW BLOOD GLUCOSE LEVELS AND IT MAY HAVE BEEN DUE TO ACCIDENTAL BUTTON PRESSING. SHE TREATED HER LOW BLOOD GLUCOSE WITH GLUCOSE TABLETS AND FOOD. THE CUSTOMER RECEIVED THE VOLUNTARY SCROLL WRAP RECALL LETTER. SHE WANTED THE INSULIN PUMP REPLACED. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406667 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other