BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4100780 · Received September 16, 2014

    Report

    Report Number
    2032227-2014-23296
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    August 16, 2014
    Report Date
    August 16, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4). CURRENTLY IT IS UNK 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 INFO WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    INSULIN PUMP ALARMED PRIME DURING BASIC OCCLUSION TEST DUE TO FAULTY FORCE SENSOR. INSULIN PUMP HAD MINOR SCRATCHED LCD WINDOW, CRACKED CASE ON DISPLAY WINDOW CORNER, CRACKED RESERVOIR TUBE LIP, SCRATCHED RESERVOIR TUBE WINDOW AND STAINED END CAP STICKER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE INSULIN PUMP ALARMED DURING THE MANUAL PRIME. CUSTOMER'S BLOOD GLUCOSE WAS 433 MG/DL, TREATED WITH DEVICE. TROUBLESHOOTING WAS PERFORMED. CUSTOMER'S SPOUSE WAS ADVISED TO DISCONNECT FROM CUSTOMER. THE DEVICE WAS NOT DROP OR BUMP PRIOR TO THE ALARM OCCURRING. CUSTOMER WAS ADVISED TO CONTINUE DISCONNECTED. CUSTOMER'S SPOUSE STATED THE DRIVE SUPPORT CAP WAS NORMAL AND CUSTOMER DID NOT PRESSED IT IN. CUSTOMER'S SPOUSE WAS ADVISED TO CONTINUE USE OF THE DEVICE AND REVENT TO BACK UP PLAN. NO. FURTHER INFO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571875 PARADIGM REAL-TIME INSULIN INFUSION PUMP OYC MEDTRONIC MINIMED MMT-722NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR