BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESERVOIR 3ML

    MDR report key: 4123046 · Received September 26, 2014

    Report

    Report Number
    2032227-2014-29580
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    June 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    FRN
    PMA / PMN Number
    K032005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATED ONE OPENED/USED RESERVOIR AND CHECKED O-RINGS/STOPPER GROOVE FOR ANOMALIES NONE WERE FOUND. RAN BASAL, BOLUS, AND LEAKING TEST AS FOLLOW: THE RESERVOIR FILLED WITH DILUENT AND CONNECTED TO A NEW INFUSION SET. INSTALLED THE RESERVOIR AND THE CONNECTOR INTO AN INSULIN PUMP. CONCLUSION: THE RESERVOIR DID NOT LEAK AND WAS NOT OCCLUDED.

    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.SEE MEDWATCH REPORT # 2032227-2014-29577.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE INSULIN PUMP ALARMED NO DELIVERY. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL, TREATED WITH INJECTION. ALARM AND POSSIBLE CAUSES WERE EXPLAINED TO THE CUSTOMER. CUSTOMER THREW AWAY RESERVOIR AND INFUSION SET. POSSIBLE OCCLUSION TO RESERVOIR OR INFUSION SET. CUSTOMER REVERTED TO BACK UP. CUSTOMER ALSO REPORTED THE RESERVOIR HAD A POSSIBLE LEAK. CUSTOMER NOTICED THE SMELL OF INSULIN WHILE SHE WAS DRIVING. CUSTOMER REPORTED ONE ISOLATED TIME THERE WAS A DROP OF INSULIN, WHEN ASKED THE LOCATION OF THE LEAK. THE BARREL WAS NO SPLIT OR CRACKED. CUSTOMER DID NOT KNOW THE SOURCE OF THE LEAK. NO FURTHER INFORMATION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600465 RESERVOIR 3ML RESERVOIR FRN MEDTRONIC MINIMED MMT-332A HG00HR6

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR