BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIBRE SENSOR FREESTYLE

    MDR report key: 15010764 · Received July 14, 2022

    Report

    Report Number
    2954323-2022-23994
    Event Type
    Malfunction
    Date Received
    July 14, 2022
    Date of Event
    July 11, 2022
    Report Date
    December 28, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. AT THIS TIME PRODUCT HAS NOT YET BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. DHRS FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FS LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, A PHYSICAL INVESTIGATION WILL BE PERFORMED AND A FOLLOW-UP REPORT SUBMITTED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. THE SENSOR PLUG IS FULLY SEATED AND NO ISSUES WERE OBSERVED. EXTRACTED DATA FROM THE RETURNED SENSOR USING APPROVED SOFTWARE. THE SENSOR WAS FOUND TO BE IN SENSOR STATE 5 (INDICATING NORMAL TERMINATION). INSPECTED THE PLUG ASSEMBLY. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR AND CONTAMINATION WAS OBSERVED ON PCBA TRIANGLE. PQE PHYSICALLY INSPECTED THE RETURNED PUCK AND REVIEWED THE ATTACHMENT FROM THE PHASE 1 INVESTIGATION AND OBSERVED THE COSMETIC DAMAGE TO THE UNDERSIDE OF THE PLUG ASSEMBLY. PQE DETERMINED THE COSMETIC DAMAGE OBSERVED WAS NOT SEVERE ENOUGH TO HAVE ANY IMPACT ON THE SENSORS ACCURACY AND DID NOT PREVENT THE PLUG ASSEMBLY FROM SEATING CORRECTLY. PQE ALSO OBSERVED DISCOLORATION ON THE PLUG CONTACT POINTS. THE DISCOLORATION APPEARS TO BE SMALL VARIATIONS IN THE GOLD-PLATING PROCESS DURING MANUFACTURING. PQE DETERMINED THE DISCOLORATION OBSERVED WAS NOT SEVERE ENOUGH TO HAVE ANY IMPACT ON THE SENSORS ACCURACY. THE SENSOR WAS REPROGRAMMED. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE BOTH WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CUSTOMER REPORTED RECEIVING ERRONEOUS GLUCOSE RESULTS FROM AN ABBOTT DIABETES CARE DEVICE. THE RESULTS WHEN PLOTTED ON A PARKES ERROR GRID FELL INTO EITHER THE C, D, OR E ZONE. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908128 LIBRE SENSOR FREESTYLE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71536-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown