BEUDAMED
    FDA Adverse Event Injury Summary report: N

    530G INSULIN PUMP

    MDR report key: 6174297 · Received December 14, 2016

    Report

    Report Number
    2032227-2016-49844
    Event Type
    Injury
    Date Received
    December 14, 2016
    Date of Event
    November 14, 2016
    Report Date
    November 17, 2016
    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
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP MONITORED FOR SEVERAL DAYS. THE INSULIN PUMP WAS RECEIVED WITH ALL OPERATING CURRENTS WITHIN SPEC AND PASSED FUNCTIONAL TESTING INCLUDING THE REWIND, UNEXPECTED RESTART ERROR TEST, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, EXCESSIVE NO DELIVERY TEST AND DISPLACEMENT TEST. NO UNEXPECTED OFF NO POWER ANOMALIES NOTED. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHED LCD WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNERS, CRACKED LCD WINDOW AND CRACKED RESERVOIR TUBE LIP.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THEY RECEIVED OFF NO POWER ALARM. THE CUSTOMER STATED THAT THEY HAD HIGH BLOOD GLUCOSE OVER 600 MG/DL AT THE TIME OF INCIDENT. THE CUSTOMER STATED THAT THEY RECEIVED LOW BATTERY ALERT PRIOR TO OFF NO POWER ALARM. THE CUSTOMER STATED THAT THEY TREATED THE HIGH BLOOD GLUCOSE WITH MANUAL INJECTION. THE INSULIN PUMP WAS RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    823913 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Other