BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRE 14 DAY

    MDR report key: 13524544 · Received February 14, 2022

    Report

    Report Number
    2954323-2022-04982
    Event Type
    Injury
    Date Received
    February 14, 2022
    Date of Event
    January 30, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    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. NO PRODUCT HAS BEEN RETURNED. AN EXTENDED INVESTIGATION HAS BEEN PERFORMED ON THE REPORTED COMPLAINT AND IT HAS BEEN DETERMINED THAT THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATIONS. THE DHR FOR THE PRECISION STRIPS WAS REVIEWED AND THE DHR SHOWED THE PRECISION STRIPS PASSED ALL TESTS PRIOR TO RELEASE. RETAIN TESTING WAS PERFORMED FOR PRECISION STRIPS AND ALL UNITS PERFORMED IN THE SPECIFICATION AND PASSED. THE DHR FOR THE LIBRE READER WAS REVIEWED AND THE DHR SHOWED THE LIBRE READER PASSED ALL TESTS PRIOR TO RELEASE. IF THE PRODUCT IS RETURNED, THE CASE WILL BE RE-OPENED, AND A PHYSICAL INVESTIGATION WILL BE PERFORMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    THE PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    A CALLER REPORTED THAT THE FREESTYLE LIBRE READER WOULD NOT TURN ON WHEN INSERTING TEST STRIP, BUT WOULD WITH BUTTON PRESS. AS A RESULT, THE CUSTOMER'S KETONE RESULTS WERE UNABLE TO BE OBTAINED. THE CUSTOMER BECAME WEAK, HAD BLURRED VISION, HAD DIFFICULTY SPEAKING, AND WAS VOMITING, AND WAS GIVEN VOGALENE (MESORIDAZINE), THEN TAKEN TO PEDIATRIC HOSPITAL. THE CALLER REPORTED THE CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS BUT DID NOT PROVIDE TREATMENT INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    A CALLER REPORTED THAT THE FREESTYLE LIBRE READER WOULD NOT TURN ON WHEN INSERTING TEST STRIP, BUT WOULD WITH BUTTON PRESS. AS A RESULT, THE CUSTOMER'S KETONE RESULTS WERE UNABLE TO BE OBTAINED. THE CUSTOMER BECAME WEAK, HAD BLURRED VISION, HAD DIFFICULTY SPEAKING, AND WAS VOMITING, AND WAS GIVEN VOGALENE (METOPIMAZINE), THEN TAKEN TO PEDIATRIC HOSPITAL. THE CALLER REPORTED THE CUSTOMER WAS DIAGNOSED WITH DIABETIC KETOACIDOSIS, BUT DID NOT PROVIDE TREATMENT INFORMATION. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050041 FREESTYLE LIBRE 14 DAY FLASH GLUCOSE MONITORING SYSTEM PZE ABBOTT DIABETES CARE INC 71938-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention