BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 4823045 · Received June 6, 2015

    Report

    Report Number
    3004209178-2015-63306
    Event Type
    Malfunction
    Date Received
    June 6, 2015
    Date of Event
    May 16, 2015
    Report Date
    May 19, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT THE INSULIN PUMP ALARMED NO DELIVERY DURING THE MANUAL PRIME DUE TO A POSSIBLE INFUSION SET, SITE, OR RESERVOIR OCCLUSION. THE CUSTOMER MENTIONED THAT SHE HAD USED 6 SETS BEFORE BEING ABLE TO RESOLVE THE NO DELIVERY ALARM. THE CUSTOMER DID NOT KNOW THE BLOOD GLUCOSE READING. SHE WAS UNABLE TO TROUBLESHOOT AT THE TIME OF THE CALL. SHE STATED THAT SHE HAD RECEIVED 6 NO DELIVERY ALARMS ON 6 DIFFERENT SETS. SHE WAS UNABLE TO DETERMINE THE CAUSE OF THE ALARM. THE CUSTOMER WAS ADVISED TO DISCONNECT FROM THE DEVICE, DISCONNECT THE TUBING AND RESERVOIR, THEN RECONNECT THE TUBING AND RESERVOIR. SHE VERIFIED THAT INSULIN EXITED WITH A MANUAL PLUNGER PUSH. SHE DID NOT HAVE ENOUGH INSULIN IN THE CURRENT RESERVOIR TO COMPLETE THE TROUBLESHOOT PROCEDURE. SHE WAS ADVISED TO REPLACE THE RESERVOIRS AND INFUSION SETS. THE CUSTOMER REPORTED THAT THE ALARM WAS RESOLVED BY A COMPLETE SET CHANGE AND REQUESTED TO RETURN THE INFUSION SET AND RESERVOIR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366753 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR UNOMEDICAL INFUSION SET