BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4041933 · Received August 27, 2014

    Report

    Report Number
    3004209178-2014-97627
    Event Type
    Injury
    Date Received
    August 27, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 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
    VA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP HAD BROKEN BATTERY TUBE THREADS, A CRACKED RESERVOIR TUBE LIP, CRACKED RESERVOIR TUBE WINDOW AND A SCRATCHED DISPLAY WINDOW. THE INSULIN PUMP PASSED THE DISPLACEMENT TEST, REWIND, BASIC OCCLUSION TEST, OCCLUSION TEST, PRIME TEST AND EXCESSIVE NO DELIVERY ALARM TEST.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A CRACK ON THE TOP OF THE BATTERY COMPARTMENT, AND STATED SHE IS NOT ABLE TO GET THE BATTERY CAP OFF. CUSTOMER'S BLOOD GLUCOSE READING WAS 49 MG/DL. CUSTOMER'S LOW BLOOD GLUCOSE WAS RELATED TO POSSIBLY EXERCISING AND TAKING INSULIN THROUGH A SYRINGE, WHICH SHE NORMALLY DOES NOT DO. CUSTOMER WAS CONNECTED TO THE PUMP WHILE LOW BLOOD GLUCOSE OCCURED. NO SIGNIFICANT EVENTS LEADING TO THE ALARM WERE OBSERVED. ADVISED DISCONTINUATION OF THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    520138 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR