BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 5894532 · Received August 22, 2016

    Report

    Report Number
    3004209178-2016-68981
    Event Type
    Malfunction
    Date Received
    August 22, 2016
    Date of Event
    July 26, 2013
    Report Date
    August 26, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    FAILURE ANALYSIS STATES THAT THE INSULIN PUMP WAS UNABLE TO PRIME DURING PRIME/A33 ALARM TEST DUE TO FAULTY FORCE SENSOR RESISTOR (GOLD). ANALYSIS WAS UNABLE TO PERFORM BASIC OCCLUSION, OCCLUSION AND EXCESSIVE NO DELIVERY ALARM TEST DUE TO PRIME ANOMALY. MOISTURE DAMAGE NOTED ON LCD BOARD. THE INSULIN PUMP HAD A CRACKED RESERVOIR TUBE LIP, CRACKED BATTERY TUBE THREADS, CRACKED CASE NEAR DISPLAY WINDOW CORNERS AND MISSING END CAP STICKER NOTED DURING VISUAL INSPECTION. NOTE: THIS IS A REMEDIATION MDR. MEDTRONIC DIABETES IMPLEMENTED REVISED MDR REPORTABILITY CRITERIA EFFECTIVE ON JULY 1, 2014. SUBSEQUENTLY, MEDTRONIC DIABETES CONDUCTED A ONE YEAR RETROSPECTIVE REVIEW OF COMPLAINTS. THIS EVENT WAS RETROSPECTIVELY IDENTIFIED TO BE REPORTABLE BASED ON THE REVISED MDR REPORTABILITY CRITERIA.

    Description of Event or Problem · 1

    THE CUSTOMER'S FRIEND REPORTED VIA PHONE CALL THAT THE INSULIN PUMP HAD MOISTURE DAMAGE, DAMAGE. THE CUSTOMER STATED THE NUMBERS ON THEIR KEYPAD WERE NOT RAMPING. THE CUSTOMER'S BLOOD GLUCOSE READING WAS 250 MG/DL. FRIEND STATED THE INSULIN PUMP WAS EXPOSED TO URINE. SHE STATED THE BUTTONS ARE UNRESPONSIVE AND THERE ARE SOME CRACKS ON THE CASING. THE FRIEND STATED SHE WAS UNABLE TO PROGRAM A BOLUS DUE TO UNRESPONSIVE BUTTONS. THE CUSTOMER WAS ADVISED TO DISCONTINUE USE OF THE DEVICE AND REVERT TO A BACK-UP PLAN. THE CUSTOMER WAS ADVISED THAT THE DEVICE WOULD BE REPLACED AND AGREED TO RETURN THE PRODUCT FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544971 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522NAB

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR