BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4142267 · Received October 5, 2014

    Report

    Report Number
    2032227-2014-33672
    Event Type
    Injury
    Date Received
    October 5, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    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. THE DEVICE HAS BEEN RETURNED, BUT NOT YET EVALUATED. FURTHER INFORMATION WILL FOLLOW ONCE THE ANALYSIS HAS BEEN COMPLETED. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE DISPLACEMENT, REWIND, BASIC OCCLUSION, OCCLUSION, PRIME AND EXCESSIVE NO DELIVERY ALARM TESTS. THE INSULIN PUMP WAS PROGRAMMED WITH MULTIPLE BOLUS DELIVERIES AND ALL REGISTERED PROPERLY IN THE BOLUS HISTORY. NO HISTORY ANOMALY WAS NOTED. NO RESET ERROR ALARM OR RESET ANOMALY WAS NOTED DURING TESTING. THE INSULIN PUMP PASSED THE RESET ERROR TEST. THE TEST TRANSMITTER COMMUNICATED PROPERLY TO THE INSULIN PUMP. THE INSULIN PUMP WAS RECEIVED WITH MINOR SCRATCHES ON THE DISPLAY WINDOW, CRACKED BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP AND CRACKED RESERVOIR TUBE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT INSULIN PUMP IS DAMAGED AND NOT WORKING. CUSTOMER REPORTED THAT THE INSULIN PUMP IS CRACKED WITH SCRATCHES ON THE SCREEN. CUSTOMER STATED THAT THE BOLUS HISTORY IS NOT RECORDING HER HISTORY. UPON REVIEWING BOLUS HISTORY, IT WAS FOUND THAT THE HISTORY SKIPPED TWO DAYS. CUSTOMER ADVISED THAT SHE DID NOT SKIP ANY DAYS USING THE PUMP. CUSTOMER STATED BLOOD GLUCOSE ROSE OVER 600 MG/DL. CUSTOMER'S CURRENT BLOOD GLUCOSE READING WAS 363 MG/DL. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622212 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-523NAS

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR