BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3852405 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-85444
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    August 31, 2013
    Report Date
    May 10, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA
    Reporter Occupation
    PATIENT

    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 INCLUDING THE DISPLACEMENT TEST. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS. THE DEVICE WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE INSULIN PUMP WAS CRACKED AROUND THE RESERVOIR COMPARTMENT. THE CALLER STATED THAT SHE IS NOT AWARE OF DROPPING THE DEVICE. THE CUSTOMER EXPERIENCED HIGH BLOOD GLUCOSE AND VOMITING; SHE BELIEVES THAT HER HIGH BLOOD GLUCOSE MAY BE CONTRIBUTED TO THE FACT THAT SHE LEAVES THE INSULIN ON THE COUNTER AND NOT REFRIGERATED. DURING THE CALL, THE CUSTOMER MENTIONED THAT HER HOSPITALIZATION AND HIGH BLOOD GLUCOSE WAS DUE TO THE STOMACH BUG. THE BLOOD GLUCOSE READING WAS 144MG/DL. THE CALLER STATED THAT THE PARAMEDICS WERE CALLED AT THE END OF AUGUST LAST YEAR AND HER BLOOD GLUCOSE LEVEL WAS IN THE COUPLE HUNDREDS OR SO, AND BACK AND FORTH. THE CUSTOMER STATED THAT SHE STAYED IN THE HOSPITAL FOR FOUR TO FIVE DAYS. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328573 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-551NAH

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization