BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SENSOR MMT-7020C4 GS3 5PK 2L CANADA

    MDR report key: 19154186 · Received April 22, 2024

    Report

    Report Number
    2032227-2024-155504
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    March 29, 2024
    Report Date
    July 12, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OZP
    UDI-DI
    002076300017961202
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BELOW CODES ARE NOT ACCEPTING IN H6 SECTION. INVESTIGATION FINDINGS CODE - 2522. INVESTIGATION CONCLUSIONS CODE - 4315. FOLLOWING OUR RECEIPT OF THE TWO RETURNED USED SENSORS/TWO NEEDLE HUBS, TOOK ONE SENSOR AT RANDOM AND PERFORMED A VISUAL INSPECTION AND FOUND THE SENSOR AND THE INSERTION NEEDLE HUB STILL ATTACHED AND THE NEEDLE IS BENT INSIDE THE SENSOR BASE PREVENTING RETRACTION. THEN FOUND THE TIP TO HAVE A BLUNT POINT. ALSO FOUND THE SENSOR LINER ADHESIVE TAPE SPLIT IN TWO PIECES, ONE ATTACHED TO SENSOR BASE AND THE REMAINDER ADHESIVE TO THE LINER TAPE. IN SUMMARY, THE CUSTOMER COMPLAINT OF SG V BG COULD NOT BE CONFIRMED. HOWEVER, THE NEEDLE/LINER ANOMALY IS CONFIRMED. BECAUSE THE SENSOR WAS ALREADY OPENED OR USED WHEN WE RECEIVED IT FOR TESTING, IT IS IMPOSSIBLE TO DETERMINE WHEN OR HOW THIS HAPPENED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    THIS MDR RELATED TO THE PUERTO RICO MANUFACTURING SITE HAS BEEN ASSIGNED A MEDWATCH NUMBER FROM THE MEDTRONIC MINIMED NORTHRIDGE SITE, PER VARIANCE 5. SELECT PATIENT INFORMATION CANNOT BE PROVIDED DUE TO REGIONAL PRIVACY REGULATIONS. 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED TO MEDTRONIC MINIMED THAT THE CUSTOMER EXPERIENCED SENSOR GLUCOSE VS. BLOOD GLUCOSE, DAMAGE (OUT OF BOX/PACKAGE). THE CUSTOMER REPORTED HEMORRHAGE/BLEEDING WHICH DID NOT REQUIRE TREATMENT. THE EVENT INVOLVED PRODUCT(S) MMT-7020C4. TROUBLESHOOTING WAS PERFORMED, CUSTOMER IS REPORTING A DISCREPANCY BETWEEN SENSOR GLUCOSE AND BLOOD GLUCOSE WHICH IS NOT WITHIN RANGE. CUSTOMER TAKES MEDICATION THAT MAY CAUSE SESNOR GLUCOSE TO BE INACCURATE. CUST IS REPORTING THE SENSOR LINER STAYED ON THE BASE WHILE PULLING THE SENSOR SERTER OFF. CUSTOMER REPORTED BLOOD AT SITE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. MMT-7020C4 WAS REQUESTED AND CUSTOMER RESPONSE WAS THE DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1695239 SENSOR MMT-7020C4 GS3 5PK 2L CANADA AUTOMATED INSULIN DOSING DEVICE SYSTEM, SINGLE HORMONAL CONTROL OZP MEDTRONIC PUERTO RICO OPERATIONS CO. MMT-7020C4 HG7Q5A6 002076300017961202

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Unknown