BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE

    MDR report key: 7958347 · Received October 11, 2018

    Report

    Report Number
    2954323-2018-07650
    Event Type
    Injury
    Date Received
    October 11, 2018
    Date of Event
    September 12, 2018
    Report Date
    May 15, 2019
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO PRODUCT HAS BEEN RETURNED, EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DHRS (DEVICE HISTORY REVIEW) FOR THE LIBRE SENSOR AND LIBRE SENSOR KIT WERE REVIEWED AND SHOWED THE 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. SECTION (DESCRIBE EVENT OR PROBLEM) HAD INCORRECT VERBIAGE IN THE PREVIOUS REPORT AND HAS SINCE BEEN UPDATED TO THE APPROPRIATE TEXT.

    Description of Event or Problem · 0

    A HEALTHCARE PROVIDER REPORTED A CUSTOMER RECEIVED HIGHER READINGS ON THE CUSTOMER¿S ADC FREESTYLE LIBRE SENSOR THAN READINGS ON A COMPETITOR¿S METER AND A LABORATORY RESULT. THE COMPARISONS ARE: SENSOR: 232 MG/DL VS METER: 188 MG/DL, SENSOR: 271 MG/DL VS METER: 205 MG/DL, SENSOR: 358 MG/DL VS METER: 295 MG/DL. ADDITIONALLY, A LABORATORY RESULT OF 150 MG/DL WAS RECEIVED AT 14:00. THE DATE WHEN THE READINGS WERE OBTAINED IS UNKNOWN. CALLER FURTHER REPORTED THAT ON (B)(6) 2018 AT 14:00 CUSTOMER EXPERIENCED A ¿HEADACHE AND TREMORS OF THE EXTREMITIES¿. CUSTOMER WAS TREATED WITH ¿GLUCOSE ACCORDING TO THE WEIGHT AND HEIGHT¿. ATTEMPTS TO CLARIFY DETAILS OF THIS EVENT HAVE BEEN UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER'S PRODUCTS HAVE BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE FILED ONCE THE PRODUCT IS RETURNED OR ADDITIONAL INFORMATION IS OBTAINED. THE ACTUAL DATE WHEN THE EVENT OCCURRED IN UNKNOWN. THE DATE OF MANUFACTURE IS UNKNOWN. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 1

    DUE: (B)(4), 71537-01. A HEALTHCARE PROVIDER REPORTED A CUSTOMER RECEIVED HIGHER READINGS ON THE CUSTOMER¿S ADC FREESTYLE LIBRE SENSOR THAN READINGS ON A COMPETITOR¿S METER AND A LABORATORY RESULT. THE COMPARISONS ARE: SENSOR: 232 MG/DL VS METER: 188 MG/DL, SENSOR: 271 MG/DL VS METER: 205 MG/DL, SENSOR: 358 MG/DL VS METER: 295 MG/DL. ADDITIONALLY, A LABORATORY RESULT OF 150 MG/DL WAS RECEIVED AT 14:00. THE DATE WHEN THE READINGS WERE OBTAINED IS UNKNOWN. CALLER FURTHER REPORTED THAT ON (B)(6) 2018 AT 14:00 CUSTOMER EXPERIENCED A ¿HEADACHE AND TREMORS OF THE EXTREMITIES¿. CUSTOMER WAS TREATED WITH ¿GLUCOSE ACCORDING TO THE WEIGHT AND HEIGHT¿. ATTEMPTS TO CLARIFY DETAILS OF THIS EVENT HAVE BEEN UNSUCCESSFUL. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    797953 FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71702-01

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Required Intervention