BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM INSULIN INFUSION PUMP

    MDR report key: 2993632 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-91646
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LZG
    PMA / PMN Number
    K040676
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    PRIME ALARM DURING BASIC OCCLUSION TEST DUE TO LOOSE/PROTRUDING DRIVE SUPPORT DISK. CRACKED RESERVOIR TUBE LIP AND CRACKED CASE NEAR RESERVOIR WINDOW NOTED DURING VISUAL INSPECTION.

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNKNOWN WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT INSULIN SQUIRTED OUT WHILE PRIMING AND THE DEVICE ALARMED. THE BLOOD GLUCOSE READING WAS 165MG/DL. THE CUSTOMER STATED THAT SHE ATTEMPTED TO REWIND SEVERAL TIMES WITHOUT RESULTS. TROUBLESHOOTING WAS PERFORMED. THE CALLER STATED THAT THE DRIVE SUPPORT CAP WAS PROTRUDED. ADVISED THE CUSTOMER TO DISCONTINUE THE USE OF THE DEVICE AND REVERT TO BACK UP PLAN. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98279 PARADIGM INSULIN INFUSION PUMP INSULIN INFUSION PUMP LZG MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-715NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR