BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4765516 · Received May 12, 2015

    Report

    Report Number
    2032227-2015-15380
    Event Type
    Injury
    Date Received
    May 12, 2015
    Date of Event
    April 12, 2015
    Report Date
    April 21, 2015
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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. 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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP WAS RECEIVED UNABLE TO PRIME DURING PRIME/A33 TEST DUE TO FAULTY FORCE SENSOR RESISTOR. UNABLE TO COMPLETE FUNCTIONAL TESTING DUE TO PRIME ANOMALY. THE INSULIN PUMP HAS CRACKED CASE ON THE DISPLAY WINDOW CORNERS, MINOR SCRATCHED LCD WINDOW, CRACKED RESERVOIR TUBE, BROKEN RESERVOIR TUBE LIP, AND BROKEN BATTERY TUBE THREADS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED VIA PHONE CALL THAT SHE WAS HOSPITALIZED FOR DIABETIC KETOACIDOSIS ON (B)(6) 2015. CUSTOMER'S BLOOD GLUCOSE WAS 600 MG/DL AT THE TIME. CUSTOMER'S CURRENT BLOOD GLUCOSE IS 100-415 MG/DL. CUSTOMER STATED THAT SHE WAS EXTREMELY DEHYDRATED. CUSTOMER STATED THAT HER BODY PHYSICALLY HURT AND SHE HAD MODERATE KETONES. CUSTOMER WAS CURRENTLY ON COMPLETE INJECTIONS. CUSTOMER'S BLOOD GLUCOSE KEPT CLIMBING FROM THE MID 300'S MG/DL TO 400'S MG/DL. CUSTOMER STATED THAT SHE TOOK EXTRA INSULIN AND SYRINGES. CUSTOMER GAVE HERSELF AN INJECTION. CUSTOMER WAS HOSPITALIZED FOR 4 DAYS AND WAS IN THE INTENSIVE CARE UNIT BECAUSE THEY HAD TO KEEP HER ON AN INSULIN DRIP. CUSTOMER WAS WEARING THE PUMP AT THE TIME OF THE 911 CALL. CUSTOMER WORE THE PUMP FOR A LITTLE BIT BUT WAS OFF THE PUMP FOR MOST OF THE TIME. CUSTOMER STATED THERE WAS DAMAGE AROUND THE OUTSIDE OF THE RESERVOIR ON THE RIM AND THE TOP OF THE BATTERY CAP. CUSTOMER DECLINED TROUBLESHOOTING AND WANTED A REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309153 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-523LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization