BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7136670 · Received December 20, 2017

    Report

    Report Number
    2954323-2017-08982
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    November 25, 2017
    Report Date
    November 20, 2018
    Manufacturer
    ABBOTT DIABETES CARE INC.
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED AND AN INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. IT SHOULD BE NOTED THAT FOR READINGS OBTAINED VIA SENSOR SCAN ANY READING THAT IS LESS THAN 40 MG/DL WILL BE DISPLAYED AS A "LO" DISPLAY MESSAGE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RETURNED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE REPORTED COMPLAINT DOES NOT PERTAIN TO THE FREESTYLE LIBRE READER. THEREFORE NO FURTHER INVESTIGATION INTO THE READER WILL BE REQUIRED. DHRS (DEVICE HISTORY REVIEW) FOR THE FREESTYLE LIBRE SENSOR AND SENSOR KIT WERE REVIEWED, AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. ALL REVIEW ACTIVITIES CONDUCTED ABOVE, INCLUDING BUT NOT LIMITED TO THE FINAL RELEASE TESTING SPECIFICALLY ASSOCIATED WITH THE MANUFACTURE OF THIS PRODUCT, ARE SUFFICIENT INFORMATION IN ORDER TO SHOW IF THE PRODUCT HAS MET SPECIFICATIONS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED AND A PHYSICAL INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS ADC FREESTYLE LIBRE SENSOR ALWAYS PROVIDED A MESSAGE 'LO' (READING LESS THAN 40 MG/DL) AND ON (B)(6), HE EXPERIENCED SYMPTOMS DESCRIBED AS "SWEATING, WITHOUT MOBILITY, AND DEHYDRATION". CUSTOMER HAD CONTACT WITH A HEALTHCARE PROVIDER AND A READING OF 280 MG/DL WAS OBTAINED AND COMPARED TO A REPORTED SENSOR RESULT OF "20 MG/DL". THE COMPARISON WAS REPORTED TO HAVE BEEN TAKEN WITHIN 3 MINUTES OF ONE ANOTHER. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN INJECTION OF INSULIN. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, OR MISTREATMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    CUSTOMER REPORTED HIS ADC FREESTYLE LIBRE SENSOR ALWAYS PROVIDED A MESSAGE 'LO' (READING LESS THAN 40 MG/DL) AND ON (B)(6) HE EXPERIENCED SYMPTOMS DESCRIBED AS "SWEATING, WITHOUT MOBILITY, AND DEHYDRATION". CUSTOMER HAD CONTACT WITH A HEALTHCARE PROVIDER AND A READING OF 280 MG/DL WAS OBTAINED AND COMPARED TO A REPORTED SENSOR RESULT OF "20 MG/DL". THE COMPARISON WAS REPORTED TO HAVE BEEN TAKEN WITHIN 3 MINUTES OF ONE ANOTHER. CUSTOMER WAS DIAGNOSED WITH HYPERGLYCEMIA AND TREATED WITH AN INJECTION OF INSULIN. 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
    913279 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC. 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention