BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 6014645 · Received October 10, 2016

    Report

    Report Number
    2032227-2016-28768
    Event Type
    Malfunction
    Date Received
    October 10, 2016
    Date of Event
    September 13, 2016
    Report Date
    October 12, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PASSED FUNCTIONAL TESTING INCLUDING SELF-TEST, A21 ERROR TEST, DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST, OFF NO POWER TEST AND EXCESSIVE NO DELIVERY TEST. ALL OPERATING CURRENTS ARE WITHIN SPECIFICATION. NO UNEXPECTED LOW BATTERY OR OFF NO POWER ALARMS NOTED. NO OFF NO POWER ANOMALY NOTED. THE BATTERY ICON IS FUNCTIONING PROPERLY. NO BATTERY ICON ANOMALY NOTED. THE INSULIN PUMP WAS RECEIVED WITH CRACKED RESERVOIR TUBE LIP, MINOR SCRATCHED DISPLAY WINDOW, CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED BELT CLIP SLOT, CRACKED BATTERY TUBE THREADS AND CRACKED DISPLAY WINDOW.

    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. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED VIA PHONE CALL THAT THE DEVICE HAD ALARMED OFF NO POWER ALARM WITHOUT ALARMING A LOW BATTERY ALERT PRIOR TWICE. CUSTOMER'S BLOOD GLUCOSE WAS 130 MG/DL. CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN PER HEALTH CARE PROFESSIONALS' INSTRUCTIONS. CUSTOMER WAS ADVISED THAT THE INSULIN PUMP WILL BE REPLACED. CUSTOMER AGREED TO RETURN THE DEVICE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667203 530G INSULIN PUMP OZO OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR