BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE LIBRELINK

    MDR report key: 20293507 · Received September 24, 2024

    Report

    Report Number
    2954323-2024-37589
    Event Type
    Injury
    Date Received
    September 24, 2024
    Date of Event
    September 17, 2024
    Report Date
    November 22, 2024
    Manufacturer
    ABBOTT DIABETES CARE INC
    Product Code
    PZE
    PMA / PMN Number
    P160030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SOFTWARE INVESTIGATION: AN INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE CUSTOMER EXPERIENCED MISSING HIGH AND LOW GLUCOSE ALARMS WITH FREESTYLE LIBRELINK APPLICATION. PER THE COMPATIBILITY GUIDE, USE OF THE HUAWEI P30 LITE UNKNOWN SOFTWARE VERSION IS INCOMPATIBLE WITH THE FREESTYLE LIBRELINK APPLICATION. THIS GUIDE IS AVAILABLE TO THE USER ON THE WEBSITES WHERE THE PRODUCT IS LAUNCHED. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. SECTION D. SUSPECTED MEDICAL DEVICE AND G4 - PMA/510(K)# HAS BEEN POPULATED FOR THE FREESTYLE LIBRELINK ANDROID APPLICATION AS THIS REPORT CONCERNS A SPAIN CUSTOMER. THIS IS SAME/SIMILAR TO US FREESTYLE LIBRE 2 ANDROID APPLICATION, MODEL NUMBER 71857-01. SENSOR INVESTIGATION: AN INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE HISTORY RECORDS (DHRS) FOR THE FREESTYLE LIBRE SENSOR AND FREESTYLE LIBRE SENSOR KIT WERE REVIEWED AND THE DHRS SHOWED THE FREESTYLE LIBRE SENSOR AND SENSOR KIT PASSED ALL TESTS PRIOR TO RELEASE. SERIAL NUMBER:(B)(6). MANUFACTURING DATE (DD-MM-YY): 16-JUN-24 EXPIRATION DATE (DD-MM-YY): 30-SEP-25. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. NO FURTHER INVESTIGATION IS PLANNED. IN THE EVENT THAT PRODUCT IS RECEIVED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. THE MOST PROBABLE ROOT CAUSES ASSOCIATED WITH THIS FAILURE MODE ARE DISCONNECTED, FAULTY OR DAMAGED COMPONENTS, SOFTWARE/DATA CORRUPTION, OR MISUSE. HOWEVER, MITIGATIONS ARE IN PLACE TO REDUCE AND PREVENT SUCH ISSUES. ALL VITAL MANUFACTURING STEPS ARE VALIDATED, MONITORED, AND VERIFIED DURING MANUFACTURING TO ENSURE THE SYSTEM IS IN CONFORMANCE WITH THE VERIFIED DESIGN. ALL VITAL FUNCTIONS ARE MONITORED BY THE SYSTEM AND, WHEN NECESSARY, FUNCTION IS SUSPENDED TO SAFEGUARD AGAINST INACCURATE RESULTS. LABELING IS PROVIDED TO INSTRUCT THE USER ON THE INTENDED USE OF ALL VITAL PARTS OF THE SYSTEM TO MINIMIZE MISUSE. ALL COMPLAINTS AND COMPLAINT TRENDS ARE INVESTIGATED TO DETERMINE IF THERE IS A PRODUCT DEFECT/DEFICIENCY. IF A PRODUCT DEFECT/DEFICIENCY IS IDENTIFIED, A RISK EVALUATION IS COMPLETED AND COMPARED TO THE RISK MANAGEMENT REPORT, TO ENSURE THE RISK PROFILE HAS NOT CHANGED. ADDITIONALLY, AS A PART OF ABBOTT¿S POST-MARKET SURVEILLANCE PROCESS, ALL RISK EVALUATIONS WITH ASSOCIATED COMPLAINT DATA ARE REVIEWED ANNUALLY TO DETERMINE IF THE RISK PROFILES HAVE CHANGED AS COMPARED TO THE PRODUCT RISK MANAGEMENT REPORTS. THESE MONITORING PROCESSES ENSURE THAT ALL PRODUCT RISK PROFILES REMAIN ACCEPTABLE AND HAVE A POSITIVE BENEFIT/RISK RATIO. THE USER REPORTED MISSING HIGH AND LOW GLUCOSE ALARMS. THE REPORTED ISSUE WAS INVESTIGATED. THE REPORTED CONFIGURATION WAS NOT COMPATIBLE WITH THE CUSTOMER'S REPORTED APPLICATION. THE LATEST REVISION OF THE COMPATIBILITY GUIDE WAS AVAILABLE TO THE CUSTOMER ON THE ABBOTT DIABETES CARE WEBSITE. 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 (DEVICE HISTORY REVIEW) FOR THE FS LIBRE SENSOR AND FS LIBRE SENSOR KITS WERE REVIEWED AND THE DHRS (DEVICE HISTORY REVIEW) SHOWED THE FS LIBRE SENSOR AND SENSOR KITS PASSED ALL TESTS PRIOR TO RELEASE. THE REPORTED PRODUCT IS NOT EXPECTED TO BE RETURNED AS REPORTER INDICATED THE DEVICE WAS DISCARDED. THEREFORE, NO FURTHER INVESTIGATION IS PLANNED. IN THE EVENT THAT PRODUCT IS RECEIVED, A PHYSICAL INVESTIGATION WILL BE PERFORMED PER ADC'S ESTABLISHED PROCESSES AND PROCEDURES AND A REPORT WILL BE SUBMITTED UPON COMPLETION OF INVESTIGATION. THIS SERVES AS A CORRECTION REPORT. SECTION H11(ADDITIONAL MFG NARRATIVE) WAS INCORRECTLY UPDATED IN THE PREVIOUS REPORT. CORRECTION HAS BEEN MADE. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH HUAWEI P30 LITE WITH AN UNKNOWN OPERATING SYSTEM VERSION. THE HIGH/LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS UNAWARE OF CHANGES IN GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED SWEATING AND A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING GLUCO UP (DRINK) FOR TREATMENT FROM THE HEALTHCARE PROFESSIONAL FOR HYPOGLYCEMIA DIAGNOSIS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 0

    AN ALARM ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE IN USE WITH MA-LX1A HUAWEY, OS 10, APP VERSION 2.11. 2.11107. THE HIGH/LOW GLUCOSE ALARM DID NOT SOUND, AND THE CUSTOMER WAS UNAWARE OF CHANGES IN GLUCOSE LEVELS. THE CUSTOMER EXPERIENCED SWEATING AND A LOSS OF CONSCIOUSNESS AND WAS UNABLE TO SELF-TREAT, REQUIRING GLUCO UP (DRINK) FOR TREATMENT FROM THE HEALTHCARE PROFESSIONAL FOR HYPOGLYCEMIA DIAGNOSIS. THERE WAS NO REPORT OF DEATH OR PERMANENT IMPAIRMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1091372 FREESTYLE LIBRELINK DATA MANAGEMENT SYSTEM PZE ABBOTT DIABETES CARE INC 71732-01

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention