FREESTYLE LIBRE 3
Report
- Report Number
- 2954323-2024-13683
- Event Type
- Injury
- Date Received
- April 22, 2024
- Date of Event
- April 11, 2024
- Report Date
- May 15, 2026
- Manufacturer
- ABBOTT DIABETES CARE LTD
- Product Code
- QLJ
- UDI-DI
- 05021791002658
- PMA / PMN Number
- K213996
- Removal / Correction Number
- 2954323-11/22/25-001-C
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
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 PRODUCT HAS BEEN REQUESTED BACK FOR AN INVESTIGATION. 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. 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. 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.
ADC INVESTIGATED THIS ISSUE AND DETERMINED THAT THE SENSOR ASSOCIATED WITH THIS COMPLAINT MAY NOT MEET PRODUCT DESIGN SPECIFICATIONS AND MAY PRODUCE LOW GLUCOSE READINGS WHICH ARE NOT CLINICALLY ACCEPTABLE. THIS PRODUCT HAS BEEN DETERMINED TO BE WITHIN THE SCOPE OF THE INVESTIGATION AND ACTIONS CONDUCTED UNDER ADC FIELD ACTION FA1002-2025.
SENSOR (B)(6) HAS BEEN RETURNED AND INVESTIGATED. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED SENSOR, NO ISSUES WERE OBSERVED. DATA WAS SUCCESSFULLY EXTRACTED FROM THE RETURNED SENSOR USING APPROVE SOFTWARE. WATERMARK WAS OBSERVED AT THE BASE OF THE TAIL. THE SENSOR WAS DE-CASED AND VISUAL INSPECTION WAS PERFORMED ON THE PCBA (PRINTED CIRCUIT BOARD ASSEMBLY), AND NO ISSUES WERE OBSERVED. PERFORMED A SOURCE MEASURE UNIT (SMU) TO ENSURE THE SENSOR'S ELECTRONICS WERE FUNCTIONING CORRECTLY. POISE VOLTAGE AND SENSOR THERMISTOR TESTING WERE PERFORMED AND BOTH WERE WITHIN SPECIFICATION, INDICATING THE SENSOR WAS PROVIDING ACCURATE GLUCOSE READINGS. THEREFORE, THIS ISSUE IS NOT CONFIRMED. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
A LOW GLUCOSE SENSOR SCAN READINGS ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A CUSTOMER REPORTED RECEIVING AN UNSPECIFIED LOW GLUCOSE SENSOR SCAN ON THE ADC DEVICE COMPARED TO AN UNSPECIFIED BLOOD GLUCOSE TEST ON A COMPETITOR¿S BRAND METER. AS A RESULT, THE CUSTOMER WAS UNABLE TO PROVIDE SELF-TREATMENT AND REPORTED THEY ¿FELL OVER,¿ EXPERIENCING A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER HAD NON-HCP CONTACT, HOWEVER IT IS UNKNOWN IF TREATMENT OR INTERVENTION WAS PROVIDED. THE CUSTOMER THEN PRESENTED TO A HOSPITAL WHERE A UNKNOWN BLOOD GLUCOSE TEST WAS PERFORMED ON THE HCP METER AND WAS PROVIDED UNKNOWN TREATMENT BY THE HEALTHCARE PROVIDER (HCP) FOR A DIAGNOSES OF HYPOGLYCEMIA. THE CUSTOMER REFUSED TO PROVIDE INFORMATION ON REGARDING TREATMENT, IF ANY, BY THE HCP. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A LOW GLUCOSE SENSOR SCAN READINGS ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A CUSTOMER REPORTED RECEIVING AN UNSPECIFIED LOW GLUCOSE SENSOR SCAN ON THE ADC DEVICE COMPARED TO AN UNSPECIFIED BLOOD GLUCOSE TEST ON A COMPETITOR¿S BRAND METER. AS A RESULT, THE CUSTOMER WAS UNABLE TO PROVIDE SELF-TREATMENT AND REPORTED THEY ¿FELL OVER,¿ EXPERIENCING A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER HAD NON-HCP CONTACT, HOWEVER IT IS UNKNOWN IF TREATMENT OR INTERVENTION WAS PROVIDED. THE CUSTOMER THEN PRESENTED TO A HOSPITAL WHERE A UNKNOWN BLOOD GLUCOSE TEST WAS PERFORMED ON THE HCP METER AND WAS PROVIDED UNKNOWN TREATMENT BY THE HEALTHCARE PROVIDER (HCP) FOR A DIAGNOSES OF HYPOGLYCEMIA. THE CUSTOMER REFUSED TO PROVIDE INFORMATION ON REGARDING TREATMENT, IF ANY, BY THE HCP. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
A LOW GLUCOSE SENSOR SCAN READINGS ISSUE WAS REPORTED WITH THE ABBOTT DIABETES CARE (ADC) DEVICE. A CUSTOMER REPORTED RECEIVING AN UNSPECIFIED LOW GLUCOSE SENSOR SCAN ON THE ADC DEVICE COMPARED TO AN UNSPECIFIED BLOOD GLUCOSE TEST ON A COMPETITOR¿S BRAND METER. AS A RESULT, THE CUSTOMER WAS UNABLE TO PROVIDE SELF-TREATMENT AND REPORTED THEY ¿FELL OVER,¿ EXPERIENCING A SEIZURE AND A LOSS OF CONSCIOUSNESS. THE CUSTOMER HAD NON-HCP CONTACT, HOWEVER IT IS UNKNOWN IF TREATMENT OR INTERVENTION WAS PROVIDED. THE CUSTOMER THEN PRESENTED TO A HOSPITAL WHERE A UNKNOWN BLOOD GLUCOSE TEST WAS PERFORMED ON THE HCP METER AND WAS PROVIDED UNKNOWN TREATMENT BY THE HEALTHCARE PROVIDER (HCP) FOR A DIAGNOSES OF HYPOGLYCEMIA. THE CUSTOMER REFUSED TO PROVIDE INFORMATION ON REGARDING TREATMENT, IF ANY, BY THE HCP. NO FURTHER INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 273201 | FREESTYLE LIBRE 3 | CONTINUOUS GLUCOSE MONITORING SYSTEM | QLJ | ABBOTT DIABETES CARE LTD | 72081-01 | T60001515 | 05021791002658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention| O |