BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3073696 · Received April 23, 2013

    Report

    Report Number
    3004209178-2013-92718
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Date of Event
    March 29, 2013
    Report Date
    March 29, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    INSPECTED ONE OPENED AND USED RESERVOIR. PERFORMED MANUAL PRIME AND HIGH PRESSURE TEST PER SPECIFICATIONS. RAN PRIMING IN INSULIN PUMP. RESERVOIR PASSED PER INSPECTION. NO OCCLUDED ANOMALIES WERE FOUND DURING ANALYSIS.

    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 THAT HIS INSULIN PUMP IS MALFUNCTIONING. CUSTOMER STATED THAT HE RECEIVED A RECERTIFIED REPLACEMENT AND 3 DAYS LATER RECEIVED A MOTOR ERROR ALARM. ASSISTED CUSTOMER WITH MANUAL PRIME AND HE STATE THAT HE CAN SEE INSULIN BUILDING UP RIGHT AROUND THE QR NO DRIPS AND THE INSULIN PUMP DID NOT ALARMED. CUSTOMER ALSO STATED THAT HE SPOKE WITH HIS ATTORNEY AND SENT 2 INFUSION SETS THAT WERE ON THE INSULIN PUMP AT THE TIME OF MOTOR ERROR ALARMED FOR DOCUMENTATION. NOTHING FURTHER WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    175457 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR UNOMEDICAL INSULIN INFUSION SET