BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 5721553 · Received June 13, 2016

    Report

    Report Number
    3004209178-2016-53145
    Event Type
    Injury
    Date Received
    June 13, 2016
    Date of Event
    May 23, 2016
    Report Date
    May 24, 2016
    Product Code
    OYC
    PMA / PMN Number
    120010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE FUNCTIONAL TEST, INCLUDING THE SELF-TEST, ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. NO SOFTWARE ERROR ALARM NOTED. THE PUMP WAS MONITORED FOR 24 HOURS, NO BLANK DISPLAY WAS NOTED. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. NO ISOLATION TAPE DAMAGE NOTED ON LCD BOARD. THE PUMP WAS RECEIVED WITH CRACKED RESERVOIR CRACKED CASE AT DISPLAY WINDOW CORNER.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL OF HIGH BLOOD GLUCOSE READINGS AND SOFTWARE ERROR FROM THE INSULIN PUMP. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 200-260 MG/DL. THE CUSTOMER HAD SYMPTOMS SUCH AS LITTLE BIT OF NAUSEA. THE CUSTOMER GAVE HERSELF AN INJECTION AND CHANGED HER SET TWICE. THE CUSTOMER STATED THAT THE ALARM DID NOT OCCUR WHILE CHANGING THE SETTINGS. THE CUSTOMER STATED THAT THE ALARM DID NOT OCCUR RIGHT AFTER A BATTERY CHANGE. THE CUSTOMER WAS ADVISED TO CHECK IF THE DRIVE SUPPORT CAP IS PROTRUDED, LOOSE, STICKING OUT OR FLUSHED. THE CUSTOMER REPORTED THE DRIVE SUPPORT CAP TO BE NORMAL. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACKUP PLAN PER HEALTH CARE PROVIDER'S INSTRUCTIONS. THE CUSTOMER WILL BE SENT A REPLACEMENT PUMP. THE CUSTOMER WILL RETURN THE PUMP FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374817 530G INSULIN PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MMT-751NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Other