BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 3830662 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-84907
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 4, 2014
    Report Date
    May 2, 2014
    Product Code
    OZO
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSULIN PUMP RECEIVED IN WITH CORRUPTED HISTORY FILES. THE DEVICE PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY TESTS.

    Additional Manufacturer Narrative · 1

    CURRENTLY IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO PRODUCT HAS BEEN RETURNED. THE DEVICE WILL BE RETURNED FOR ANALYSIS AND 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 STATES THAT SHE WAS HOSPITALIZED FOR LOW BLOOD GLUCOSE. SHE STATES THAT THE INSULIN PUMP GAVE HER 100 UNITS OF INSULIN AT ONE TIME THAT CAUSED HER BLOOD GLUCOSE TO GO VERY LOW. THE BLOOD GLUCOSE AT THE TIME OF HOSPITAL ADMISSION ISN'T AVAILABLE. ALARM HISTORY SHOWED THAT THE CUSTOMER HAD RECEIVED MULTIPLE ALARMS. ADVISED CUSTOMER THE INSULIN PUMP WOULD BE REPLACED. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308298 530G INSULIN PUMP OZO OZO MMT-551NAP

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization