BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    530G INSULIN PUMP

    MDR report key: 4160138 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26291
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 21, 2014
    Report Date
    August 21, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OZO
    PMA / PMN Number
    120010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE TONE CHECK AND VIBRATE CHECK ON THE SELF TEST. THE INSULIN PUMP COMMUNICATED PROPERLY TO THE GLUCOSE SENSOR SIMULATOR AND THE TRANSMITTER. THE THRESHOLD SUSPEND ALARM FUNCTIONED PROPERLY WITH THE AUDIO TONES. NO AUDIO ANOMALY WAS NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT HIS INSULIN PUMP WENT INTO A THRESHOLD SUSPEND STATE AND THERE WAS NO ALARM INDICATING THIS. THE CUSTOMER STATED THE NIGHT BEFORE, IT DID VIBRATE, BUT THERE WAS NO SOUND. THE CUSTOMER STATED IT WAS SET ON A LONG BEEP SETTING. THE CUSTOMER STATED THAT HE HAD A READING OF 44 WHEN HIS BLOOD GLUCOSE WAS 206 MG/DL. THE CUSTOMER DECLINED TROUBLESHOOTING. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581577 530G INSULIN PUMP OZO MEDTRONIC MINIMED MMT-751NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR