BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    MDR report key: 4103842 · Received September 19, 2014

    Report

    Report Number
    2032227-2014-26573
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 22, 2014
    Manufacturer
    MEDTRONIC MINIMED
    Product Code
    OYC
    PMA / PMN Number
    P980022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    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.

    Additional Manufacturer Narrative · 1

    THE INSULIN PUMP PASSED THE REWIND, BASIC OCCLUSION, OCCLUSION, PRIME, EXCESSIVE NO DELIVERY ALARM AND DISPLACEMENT TESTS. THE INSULIN PUMP WAS PROGRAMMED WITH THE CORRECT TIME AND DATE. THE INSULIN PUMP WAS PROGRAMMED WITH A TEST GLUCOSE METER AND TRANSFERRED THE BLOOD GLUCOSE READING PROPERLY. THE INSULIN PUMP SHOWED THE BOLUS VALUES PROPERLY FROM THE GLUCOSE METER. THE INSULIN PUMP WAS MONITORED FOR THREE DAYS. SEVERAL BOLUSES WERE PROGRAMMED AND DELIVERED. ALL BOLUSES WERE PROPERLY DELIVERED AND STORED AT THE BOLUS AND DAILY TOTALS HISTORY SCREEN. NO HISTORY ANOMALIES WERE NOTED. THE INSULIN PUMP WAS RECEIVED WITH A CRACKED CASE AT THE DISPLAY WINDOW CORNERS AND BATTERY TUBE THREADS AND MINOR SCRATCHES ON THE DISPLAY WINDOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INSULIN PUMP HAD A CRACKED SCREEN AFTER IT HAD BEEN DROPPED. THE BLOOD GLUCOSE READING WAS 203 MG/DL. THE CUSTOMER STATED THAT WHEN SHE PUT INSULIN IN THROUGH A BOLUS, SHE FELT THAT THE INSULIN PUMP WAS NOT WORKING PROPERLY BECAUSE SHE HAD HIGH BLOOD GLUCOSE LEVELS IN THE 300 MG/DL RANGE. SHE REPORTED THAT THE INSULIN PUMP DID NOT RECORD THE BOLUSES SHE HAD PERFORMED AND SOME OF THE BLOOD GLUCOSE READINGS SHE HAD ENTERED; SHE STATED THAT SHE REMEMBERED ENTERING THOSE VALUES INTO THE DEVICE. ADDITIONALLY, SHE NOTED THAT THE BLOOD GLUCOSE READING WAS 199 MG/DL DURING LUNCH AND THE CARBOHYDRATES READ 37 UNITS ACCORDING TO HER PAPER LOG; HOWEVER, SHE SAID THAT THE INSULIN PUMP DID NOT RECORD THIS. SHE STATED THAT SHE WAS ABLE TO SEE THE NUMBERS COUNTING UP, AND THEN SHE STOPPED WATCHING. ADVISED THE CUSTOMER TO CONSULT WITH HER DOCTOR AND TO REPLACE THE INSULIN PUMP. NOTHING FURTHER REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582262 PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP INSULIN INFUSION PUMP / SENSOR AUGMENTED OYC MEDTRONIC MINIMED MMT-723LNAS

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR