BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP MMT-751NAH

    MDR report key: 8806250 · Received July 19, 2019

    Report

    Report Number
    2032227-2019-32517
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 20, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZO
    UDI-DI
    00643169503687
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP PASSED THE OPERATING CURRENTS, SELF TEST AND DISPLACEMENT TEST. NO UNEXPECTED BATTERY POWER LOSS ANOMALY NOTED DURING TEST. INSULIN PUMP RECEIVED WITH CRACKED BATTERY TUBE THREADS. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT INSULIN PUMP DID NOT RECEIVE A LOW BATTERY ALERT PRIOR TO THE REPLACE BATTERY ALERT OR REPLACE BATTERY NOW ALARM. BLOOD GLUCOSE WAS UNKNOWN. TROUBLESHOOTING WAS PERFORMED. CUSTOMER ALSO REPORTED THAT BATTERY COMPARTMENT WAS CRACKED. THE CUSTOMER WAS ADVISED THAT THE INSULIN PUMP NEEDED TO BE REPLACED AND WAS ADVISED TO DISCONTINUE USE OF THE INSULIN PUMP AND TO REVERT TO THE BACKUP PLAN. THE INSULIN PUMP WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600811 530G INSULIN PUMP MMT-751NAH ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND OZO MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-751NAH A4751NAHJ 00643169503687

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR