BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESERVOIR 1.8ML

    MDR report key: 3972330 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-88803
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    July 1, 2014
    Report Date
    July 1, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    FRN
    PMA / PMN Number
    K001828
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    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. SEE MEDWATCH REPORT # 2032227-2014-05132.

    Additional Manufacturer Narrative · 1

    A COMPLETE ANALYSIS AND TESTING OF THE INSULIN PUMP SHOWED THAT IT WAS FUNCTIONING PROPERLY AND PASSED ALL FUNCTIONAL TESTING. AFTER TESTING IT WAS CONCLUDED THAT THE DEVICE OPERATED WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THERE ARE AIR BUBBLES IN THE RESERVOIR AND IN THE TUBING OF THE INFUSION SET. CUSTOMER BLOOD GLUCOSE WAS 136 MG/DL. CUSTOMER STATED THAT SHE HAS BEEN LEAVING THE INSULIN OUT BEFORE FILLING LIKE ADVISED PREVIOUSLY. CUSTOMER HAS TRIED TO TAKE OUT THE BUBBLES WITH MANUAL PRIME WORKS FOR 24 HOURS THEN BUBBLES REAPPEAR. CUSTOMER STATED ONLY FOR THREE FULL DAYS SHE DID NOT HAVE ANY BUBBLES. CUSTOMER STATED THE BUBBLES APPEARED DURING NORMAL BASAL RATES AND IT SEEMS LESS APPEARED DURING TEMP BASALS. CUSTOMER STATES SHE HAS HAD HIGH BLOOD GLUCOSE BECAUSE OF THE AIR BUBBLES. TROUBLESHOOTING WAS PERFORMED. BLOOD GLUCOSE WAS REPORTED AT 13 MG/DL. THE SIZES OF THE BUBBLES ARE THE SIZE OF STRAIGHT PIN. CUSTOMER STATED THE DEVICE WAS NOT REWOUND WITH THE RESERVOIR IN PLACE. NO LEAKS NOTED. CUSTOMER WAS ADVISED TO DO A SET CHANGE AIR BUBBLE STILL PERSISTED. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447890 RESERVOIR 1.8ML RESERVOIR FRN MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-326A HG02KMW

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR