BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINIMED 530 G WITH ENLITE

    MDR report key: 4628103 · Received March 18, 2015

    Report

    Report Number
    MW5041600
    Event Type
    Injury
    Date Received
    March 18, 2015
    Date of Event
    January 12, 2015
    Report Date
    March 18, 2015
    Manufacturer
    MEDTRONIC
    Product Code
    OZO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I PURCHASED A MEDTRONIC MINIMED 530 G PUMP WITH ENLITE CGM IN (B)(6) 2014. WHILE THE PUMP PERFORMED FINE, THE CGM WAS A DISASTER FROM THE VERY START. ENILTE SENSOR READINGS WERE CONSISTENTLY 100 POINTS OFF FROM MY BS GLUCOMETER READINGS. THE CGM MONITOR SCREEN CONTINUALLY DISPLAYED A "WEAK SIGNAL" OR "LOST SIGNAL" ALARM WHEN THE PUMP WAS ONLY A SHORT DISTANCE AWAY FROM THE TRANSMITTER (IE ON THE OTHER SIDE OF MY BODY). ON (B)(6) 2015, I INSERTED A NEW SENSOR AND KEPT GETTING "LOW ALERTS" OF 65-70, BUT MY BS GLUCOMETER READING WAS LOW. ON (B)(6) AT APPROX 11:30 PM, I AWOKE ON MY OWN FEELING THAT MY BLOOD SUGAR WAS LOW. MY BS GLUCOMETER READ 54. THE ENLITE CGM WAS READING 90! IT NEVER PREDICTED A LOW, ALERTED ME TO A LOW OR SUSPENDED THE PUMP! ON (B)(6) AT 2:30 PM, THE CGM GAVE A "FALL RATE" ALARM AND THE SENSOR WAS PREDICTING A LOW AND READING 54 BUT MY BS GLUCOMETER READING WAS 197. WITHIN AN HOUR, I RECEIVED "CAL ERROR" ALERT AND "CHANGE SENSOR" ALERT. THIS WAS FIVE DAYS AFTER INITIAL INSERTION (ENLITE CGM IS SUPPOSED TO WORK FOR SIX DAYS). THE FDA NEEDS TO REVIEW MEDTRONIC'S MARKETING MATERIALS FOR THIS DEVICE, AS THERE ARE SEVERAL MISLEADING ASPECTS (EG, THE PICTURE OF THE TRANSMITTER IS DECEPTIVELY SMALL COMPARED TO THE REAL THING). ALSO, MEDTRONIC IS TOUTING THE MINIMED 530 G ENLITE AS THE LATEST INNOVATION IN "ARTIFICIAL PANCREAS TECHNOLOGY," A CLAIM WHICH IS PATENTLY FALSE. THIS IS NOT AN AUTOMATIC BG MEASUREMENT/INSULIN DELIVERY DEVICE AS THE ADVERTISEMENT WOULD SUGGEST. I'VE EVEN READ SEVERAL NEWS ARTICLES REFERRING TO THE MINIMED 530 G AS AN ARTIFICIAL PANCREAS. THIS PRODUCT SHOULD BE PULLED FROM THE MARKET IMMEDIATELY BEFORE MORE PTS ARE HARMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184423 MINIMED 530 G WITH ENLITE MINIMED 530 G WITH ENLITE OZO MEDTRONIC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention LOSARTAN| CARTIA| PRAVASTATIN| HUMALOG INSULIN| MEDTRONIC 530 G INSULIN PUMP