BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    MDR report key: 4162018 · Received October 10, 2014

    Report

    Report Number
    2032227-2014-36079
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    September 11, 2014
    Report Date
    September 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    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. THIS MDR RELATED TO THE (B)(4) MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER'S DAUGHTER THAT THE CUSTOMER HAD EXCESSIVE NO DELIVERY ALARMS ON THE INSULIN PUMP. CUSTOMER STATED THAT SHE WAS ABLE TO PROGRAM A 0.7 UNIT AND IT WENT THROUGH OKAY. CUSTOMER'S DAUGHTER STATED THAT DURING THIS TIME, HER MOTHER WAS NOT THINKING WELL DUE TO HIGH BLOOD GLUCOSE LEVELS. THIS COMPLAINT HAD BEEN REPORTED AN ADDITIONAL TWO TIMES AND TROUBLESHOOTING WAS COMPLETED. HELPLINE DETERMINED IT HAD BEEN A SITE ISSUE. CUSTOMER WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS DUE TO THE NO DELIVERY ALARM ACCORDING TO THE DAUGHTER OF THE CUSTOMER. CUSTOMER'S DAUGHTER INDICATES THAT HER MOTHER'S CARELINK REPORT SHOWS THAT THE NO DELIVERY ALARMS OCCURRED 19 TIMES BETWEEN (B)(6) AND (B)(6), HOWEVER, THESE INCIDENTS WERE NEVER REPORTED. CUSTOMER WILL BE ALLOWED TO KEEP THE PUMP AS A PERMANENT PUMP, BUT IT WILL NOT INCLUDE A WARRANTY. ORIGINAL WARRANTY WAS LATER ADDED AND CUSTOMER WAS ADVISED TO RETURN THE OTHER PUMP BACK. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644402 PARADIGM REAL-TIME INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-522LNAB

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization