FREESTYLE LIBRE 2
Report
- Report Number
- 2954323-2023-07310
- Event Type
- Death
- Date Received
- February 20, 2023
- Date of Event
- October 22, 2022
- Report Date
- August 29, 2023
- Manufacturer
- ABBOTT DIABETES CARE INC
- Product Code
- QLG
- PMA / PMN Number
- K193371
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
IT WAS INDICATED THAT THE DEVICE IN QUESTION WAS DISCARDED. NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS COMPLETED FOR THE REPORTED COMPLAINT AND LIBRE SENSOR, AND THERE WERE NO ADVERSE TRENDS THAT INDICATE ANY PRODUCT RELATED ISSUES. ADC ATTEMPTED TO REPLICATE THE USER COMPLAINT AND WAS ABLE TO SUCCESSFULLY RECEIVE HIGH/LOW GLUCOSE ALARMS ON IOS CONFIGURATION (IPHONE 8, IOS 15.6, 2.8.1.6120) AND ANDROID CONFIGURATION (SAMSUNG GALAXY S20 FE 5G, ANDROID 13, 2.8.2.9318) FOR THE UK FREESTYLE LIBRELINK APPLICATION. ADC WAS NOT ABLE TO REPLICATE THE ISSUES WITH THE LIBRELINK APP. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
IT WAS INDICATED THAT THE DEVICE IN QUESTION WAS DISCARDED. NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS COMPLETED FOR THE REPORTED COMPLAINT AND LIBRE SENSOR, AND THERE WERE NO ADVERSE TRENDS THAT INDICATE ANY PRODUCT RELATED ISSUES. ADC ATTEMPTED TO REPLICATE THE USER COMPLAINT AND WAS ABLE TO SUCCESSFULLY RECEIVE HIGH/LOW GLUCOSE ALARMS ON IOS CONFIGURATION (IPHONE 8, IOS 15.6, 2.8.1.6120) AND ANDROID CONFIGURATION (SAMSUNG GALAXY S20 FE 5G, ANDROID 13, 2.8.2.9318) FOR THE UK FREESTYLE LIBRELINK APPLICATION. ADC WAS NOT ABLE TO REPLICATE THE ISSUES WITH THE LIBRELINK APP. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
IT WAS INDICATED THAT THE DEVICE IN QUESTION WAS DISCARDED. NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS COMPLETED FOR THE REPORTED COMPLAINT AND LIBRE SENSOR, AND THERE WERE NO ADVERSE TRENDS THAT INDICATE ANY PRODUCT RELATED ISSUES. ADC ATTEMPTED TO REPLICATE THE USER COMPLAINT AND WAS ABLE TO SUCCESSFULLY RECEIVE HIGH/LOW GLUCOSE ALARMS ON IOS CONFIGURATION (IPHONE 8, IOS 15.6, 2.8.1.6120) AND ANDROID CONFIGURATION (SAMSUNG GALAXY S20 FE 5G, ANDROID 13, 2.8.2.9318) FOR THE UK FREESTYLE LIBRELINK APPLICATION. ADC WAS NOT ABLE TO REPLICATE THE ISSUES WITH THE LIBRELINK APP. THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IN SECTION H4 IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
THE CUSTOMER'S PRODUCT HAS BEEN REQUESTED FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS OBTAINED. THE EXACT DATE THAT THE INCIDENT OCCURRED IS UNKNOWN. THE DATE ENTERED IS BASED ON THE HEALTHCARE PROFESSIONAL'S REPORT OF "(B)(6) 2022". THE DEVICE MFG DATE IS UNKNOWN. THE DATE ENTERED IS THE DATE ABBOTT DIABETES CARE BECAME AWARE OF THE EVENT. ALL PERTINENT INFORMATION AVAILABLE TO ABBOTT DIABETES CARE HAS BEEN SUBMITTED.
REPEATED ATTEMPTS BY ADC TO RETRIEVE THE PRODUCT WERE UNSUCCESSFUL AND/OR THE CUSTOMER DISCARDED THE PRODUCT. NO PRODUCT HAS BEEN RETURNED AND A VALID SERIAL NUMBER HAS NOT BEEN PROVIDED. EXTENDED INVESTIGATION HAS BEEN PERFORMED FOR THE REPORTED COMPLAINT AND THERE WAS NO INDICATION THAT THE PRODUCT DID NOT MEET SPECIFICATION. A TRIPPED TREND REVIEW WAS CONDUCTED FOR THE REPORTED COMPLAINT AND FS LIBRE SENSORS, NO TRENDS WERE IDENTIFIED THAT WOULD INDICATE ANY PRODUCT RELATED ISSUES. SUCCESSFULLY RECEIVED HIGH/LOW GLUCOSE ALARMS ON IOS/ANDROID/FSLL CONFIGURATION. NO ISSUES WERE IDENTIFIED WITH THE LIBRELINK APPLICATION. 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.
AN ABBOTT DIABETES CARE (ADC) TERRITORY MANAGER RECEIVED A COMPLAINT FROM A NURSE WHO REPORTED THE DEATH OF A PATIENT, WHO WAS USING THE ADC DEVICE AT THE TIME OF DEATH. THE NURSE STATED THAT "THE INCIDENT OCCURRED IN (B)(6) 2022 AND POSSIBLY INVOLVED LOSS OF LOW GLUCOSE ALARM". ADC CUSTOMER SERVICE CONTACTED THE NURSE TO OBTAIN ADDITIONAL INFORMATION RELATED TO USERS' DEATH, AND DURING THE FOLLOW UP IT WAS LEARNED THAT THERE WERE MANY CLINICAL AND OTHER FACTORS INVOLVED IN THE PATIENT'S DEATH, HOWEVER NO FURTHER INFORMATION WAS PROVIDED DUE TO PATIENT'S CONFIDENTIALITY. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED. ON 25 APR 2023, ADC RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT, VIA MHRA NOTIFICATION , REFERENCE 2023/004/012/501/016. THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL WITH CARDIAC ARREST. IT WAS ADDITIONALLY NOTED THAT THE PATIENT HAD A RECENT HISTORY OF ONGOING HYPOGLYCEMIC EVENTS, POOR COMPLIANCE WITH DIABETES MANAGEMENT, AND POTENTIAL ALCOHOL AND DRUG ABUSE. THE PATIENT'S ADC DEVICE DATA WAS REVIEWED BY THE HEALTHCARE FACILITY, AND GAPS IN READINGS DATA WAS NOTED. IT WAS STATED THAT IT WAS UNKNOWN IF THIS WAS DUE TO DEVICE MALFUNCTION OR THE PATIENT NOT SCANNING THE SENSOR DURING THESE TIMES. ADDITIONALLY, THE NOTIFICATION INDICATED THAT THE APPLICATION VERSION IN USE WAS 2.5.3.3088 (FOR IPHONE/IOS) AND THAT THE SENSOR IN QUESTION HAS ALREADY BEEN DISCARDED. THE OFFICIAL CAUSE OF DEATH WAS NOT STATED. THEREFORE, GIVEN THE ADDITIONAL INFORMATION PRESENTED, IT REMAINS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED. ON 26-JUL-2023, ABBOTT DIABETES CARE RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE PATIENT¿S DAUGHTER AND IS CURRENTLY BEING REVIEWED BY ADC MEDICAL AFFAIRS. A FOLLOW UP WILL BE SUBMITTED ONCE THE REVIEW IS COMPLETE. ON 26-JUL-2023, ABBOTT DIABETES CARE RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE PATIENT¿S DAUGHTER, WHO PROVIDED PHOTOS OF THE PATIENT¿S FREESTYLE LIBRELINK APPLICATION READINGS HISTORY LOG AND THE PATIENT¿S AUTOPSY REPORT WHICH CONTAINED THE FOLLOWING INFORMATION: AS PER ADCS ANALYSIS OF THE DOCUMENTATION RECEIVED, PHOTOS OF THE SENSOR READINGS LOG AND THE PATIENT¿S FREESTYLE LIBRELINK APPLICATION NOTIFICATIONS SHOWED THAT ON THE NIGHT OF 20 OCT 2023, THE PATIENT OBTAINED SENSOR READINGS OF 3.5 MMOL/L (AT 20:11), 3.7 MMOL/L (AT 20:27), AND 3.7 MMOL/L (AT 20:28), 4.6 MMOL/L (AT 20:52), WITH THE LOW GLUCOSE ALARM SOUNDING AT 21:05. A SUBSEQUENT SENSOR READING OF 4.3 MMOL/L WAS OBTAINED AT 21:33. THE PATIENT THEN RECEIVED A SERIES OF ¿SIGNAL LOSS¿ WARNINGS AT 21:49, 21:54, 22:04, 22:09, AND 22:14. BASED ON THE PHOTOS OF SENSOR READINGS LOG AND FREESTYLE LIBRELINK NOTIFICATION, ADC ANALYSIS WAS THE FIRST SIGNAL LOSS ALARM WARNING OCCURRED 16 MINUTES AFTER THE LAST SENSOR READING WAS OBTAINED. IT IS UNKNOWN IF THE PATIENT OR A THIRD-PARTY MADE EFFORTS TO CORRECT THE PATIENT¿S LOW GLUCOSE, AFTER OBTAINING THE LOW SENSOR READINGS AND LOW GLUCOSE ALARM. THE POST-MORTEM REPORT INDICATED THE FOLLOWING INFORMATION: "ON THE MORNING (UNSPECIFIED TIME) OF (B)(6) 2022, A DISTRICT NURSE FOUND THE PATIENT IN WHAT WAS DESCRIBED AS A PERI-ARREST/AGONAL STATE. THE NURSE WAS INITIALLY ABLE TO PROVIDE UNSPECIFIED TREATMENT TO THE PATIENT, BUT THE PATIENT THEN SUFFERED CARDIAC ARREST AND EMERGENCY SERVICES WERE CALLED TO TRANSFER THE PATIENT TO ROYAL ALEXANDRA HOSPITAL. IT WAS NOTED THAT AT THIS TIME, THE PATIENT¿S GLUCOSE WAS ¿LOW¿ MEASURED ON AN UNKNOWN DEVICE. AT THE HOSPITAL, ADRENALINE AND FLUIDS WERE ADMINISTERED TO THE PATIENT AS RESUSCITATIVE MEASURES. THE PATIENT ENTERED A STATE OF VENTRICULAR FIBRILLATION, BEFORE SPONTANEOUSLY REGAINING CIRCULATION. BLOOD TEST RESULTS SHOWED A GLUCOSE OF 8.3 MMOL/L, LACTATE OF 4 MMOL/L, AND H+ OF 107 NMOL/L. THE PATIENT WAS 3/15 ON THE GLASGOW COMA SCALE, WITH PUPILS FIXED AND UNREACTIVE, AND PALLIATIVE CARE WAS COMMENCED. PATIENT DEATH OCCURRED ON (B)(6) 2022 AT 01:30 AS PER POST-MORTEM REPORT. THE PATIENT HAD A LONG HEALTH HISTORY, WITH RISK FACTORS, WHICH INCLUDED TYPE 1 DIABETES, CHRONIC PANCREATITIS, ALCOHOL EXCESS, CHRONIC LIVER DISEASE WITH CIRRHOSIS, THROMBOCYTOPENIA, HYPERTENSION, PERIPHERAL NEUROPATHY, AND LEFT BELOW-THE-KNEE AMPUTATION. THE PATIENT WAS ON THE FOLLOWING PRESCRIBED MEDICATIONS AT THEIR TIME OF DEATH: CREON, MACROGOL, LACTULOSE, AMITRIPTYLINE, SIMVASTATIN, ASPIRIN, THIAMINE, PREGABALIN, SPIRONOLACTONE, SENNA, FUROSEMIDE, FERROUS FUMARATE, MIRTAZAPINE AND NOVORAPID." IN ADDITION, THE POST-MORTEM AUTOPSY OF THE PATIENT INDICATED THE FOLLOWING: "MILD TO SEVERE ATHEROMATOUS NARROWING OF SEVERAL ARTERIES IN THE PATIENT¿S HEART, WITH SEVERE CALCIFIED ATHEROMATOUS NARROWING OF A MAIN VESSEL TO THE HEART. IT WAS ADDITIONALLY FOUND THAT THE PATIENT¿S TRACHEA AND BRONCHI CONTAINED THICK MUCUS." THE AUTOPSY CONCLUDED THAT THE "CAUSE OF DEATH FOR THIS PATIENT WAS BRONCHOPNEUMONIA AND CORONARY ARTERY ATHEROMA, WITH HYPOGLYCEMIA AS A POTENTIAL CONTRIBUTING FACTOR." AFTER EXAMINATION OF THE PATIENT¿S SENSOR READINGS HISTORY LOG, ADC ANALYSIS WAS THE FOLLOWING: THE PATIENT HAD OBTAINED SEVERAL LOW GLUCOSE READINGS AND A LOW GLUCOSE ALARM OVER THE SPAN OF APPROXIMATELY 2.5 HOURS, INDICATING THAT THE LIBRE SYSTEM WAS PROVIDING APPROPRIATE NOTIFICATION OF THEIR LOW GLUCOSE STATE. THEREFORE, IT IS THE OPINION OF ADCS SR. MEDICAL AFFAIRS THAT THERE WAS NO INFORMATION PROVIDED THAT COULD CONCLUDE THAT A TECHNICAL MALFUNCTION OF THE FREESTYLE LIBRE SYSTEM LED TO PATIENT TO BE UNAWARE OF THEIR HYPOGLYCEMIA WHICH WOULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT¿S ULTIMATE DEATH.
AN ABBOTT DIABETES CARE (ADC) TERRITORY MANAGER RECEIVED A COMPLAINT FROM A NURSE WHO REPORTED THE DEATH OF A PATIENT, WHO WAS USING THE ADC DEVICE AT THE TIME OF DEATH. THE NURSE STATED THAT "THE INCIDENT OCCURRED IN (B)(6) 2022 AND POSSIBLY INVOLVED LOSS OF LOW GLUCOSE ALARM". ADC CUSTOMER SERVICE CONTACTED THE NURSE TO OBTAIN ADDITIONAL INFORMATION RELATED TO USERS' DEATH, AND DURING THE FOLLOW UP IT WAS LEARNED THAT THERE WERE MANY CLINICAL AND OTHER FACTORS INVOLVED IN THE PATIENT'S DEATH, HOWEVER NO FURTHER INFORMATION WAS PROVIDED DUE TO PATIENT'S CONFIDENTIALITY. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED. ON (B)(6) 2023, ADC RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT, VIA MHRA NOTIFICATION , REFERENCE (B)(4). THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL WITH CARDIAC ARREST. IT WAS ADDITIONALLY NOTED THAT THE PATIENT HAD A RECENT HISTORY OF ONGOING HYPOGLYCEMIC EVENTS, POOR COMPLIANCE WITH DIABETES MANAGEMENT, AND POTENTIAL ALCOHOL AND DRUG ABUSE. THE PATIENT'S ADC DEVICE DATA WAS REVIEWED BY THE HEALTHCARE FACILITY, AND GAPS IN READINGS DATA WAS NOTED. IT WAS STATED THAT IT WAS UNKNOWN IF THIS WAS DUE TO DEVICE MALFUNCTION OR THE PATIENT NOT SCANNING THE SENSOR DURING THESE TIMES. ADDITIONALLY, THE NOTIFICATION INDICATED THAT THE APPLICATION VERSION IN USE WAS 2.5.3.3088 (FOR IPHONE/IOS) AND THAT THE SENSOR IN QUESTION HAS ALREADY BEEN DISCARDED. THE OFFICIAL CAUSE OF DEATH WAS NOT STATED. THEREFORE, GIVEN THE ADDITIONAL INFORMATION PRESENTED, IT REMAINS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED. ON (B)(6) 2023, ABBOTT DIABETES CARE RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT FROM THE PATIENT¿S DAUGHTER AND IS CURRENTLY BEING REVIEWED BY ADC MEDICAL AFFAIRS. A FOLLOW UP WILL BE SUBMITTED ONCE THE REVIEW IS COMPLETE.
AN ABBOTT DIABETES CARE (ADC) TERRITORY MANAGER RECEIVED A COMPLAINT FROM A NURSE WHO REPORTED THE DEATH OF A PATIENT, WHO WAS USING THE ADC DEVICE AT THE TIME OF DEATH. THE NURSE STATED THAT "THE INCIDENT OCCURRED IN (B)(6) 2022 AND POSSIBLY INVOLVED LOSS OF LOW GLUCOSE ALARM". ADC CUSTOMER SERVICE CONTACTED THE NURSE TO OBTAIN ADDITIONAL INFORMATION RELATED TO USERS' DEATH, AND DURING THE FOLLOW UP IT WAS LEARNED THAT THERE WERE MANY CLINICAL AND OTHER FACTORS INVOLVED IN THE PATIENT'S DEATH, HOWEVER NO FURTHER INFORMATION WAS PROVIDED DUE TO PATIENT'S CONFIDENTIALITY. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED. ON 25 APR 2023, ADC RECEIVED ADDITIONAL INFORMATION REGARDING THIS EVENT, VIA MHRA NOTIFICATION , REFERENCE (B)(4) . THE FOLLOWING INFORMATION WAS PROVIDED: THE PATIENT HAD BEEN ADMITTED INTO THE HOSPITAL WITH CARDIAC ARREST. IT WAS ADDITIONALLY NOTED THAT THE PATIENT HAD A RECENT HISTORY OF ONGOING HYPOGLYCEMIC EVENTS, POOR COMPLIANCE WITH DIABETES MANAGEMENT, AND POTENTIAL ALCOHOL AND DRUG ABUSE. THE PATIENT'S ADC DEVICE DATA WAS REVIEWED BY THE HEALTHCARE FACILITY, AND GAPS IN READINGS DATA WAS NOTED. IT WAS STATED THAT IT WAS UNKNOWN IF THIS WAS DUE TO DEVICE MALFUNCTION OR THE PATIENT NOT SCANNING THE SENSOR DURING THESE TIMES. ADDITIONALLY, THE NOTIFICATION INDICATED THAT THE APPLICATION VERSION IN USE WAS 2.5.3.3088 (FOR IPHONE/IOS) AND THAT THE SENSOR IN QUESTION HAS ALREADY BEEN DISCARDED. THE OFFICIAL CAUSE OF DEATH WAS NOT STATED. THEREFORE, GIVEN THE ADDITIONAL INFORMATION PRESENTED, IT REMAINS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED.
AN ABBOTT DIABETES CARE (ADC) TERRITORY MANAGER RECEIVED A COMPLAINT FROM A NURSE WHO REPORTED THE DEATH OF A PATIENT, WHO WAS USING THE ADC DEVICE AT THE TIME OF DEATH. THE NURSE STATED THAT "THE INCIDENT OCCURRED IN (B)(6) 2022 AND POSSIBLY INVOLVED LOSS OF LOW GLUCOSE ALARM". ADC CUSTOMER SERVICE CONTACTED THE NURSE TO OBTAIN ADDITIONAL INFORMATION RELATED TO USERS' DEATH, AND DURING THE FOLLOW UP IT WAS LEARNED THAT THERE WERE MANY CLINICAL AND OTHER FACTORS INVOLVED IN THE PATIENT'S DEATH, HOWEVER NO FURTHER INFORMATION WAS PROVIDED DUE TO PATIENT'S CONFIDENTIALITY. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED.
AN ABBOTT DIABETES CARE (ADC) TERRITORY MANAGER RECEIVED A COMPLAINT FROM A NURSE WHO REPORTED THE DEATH OF A PATIENT, WHO WAS USING THE ADC DEVICE AT THE TIME OF DEATH. THE NURSE STATED THAT "THE INCIDENT OCCURRED IN (B)(6) 2022 AND POSSIBLY INVOLVED LOSS OF LOW GLUCOSE ALARM". ADC CUSTOMER SERVICE CONTACTED THE NURSE TO OBTAIN ADDITIONAL INFORMATION RELATED TO USERS' DEATH, AND DURING THE FOLLOW UP IT WAS LEARNED THAT THERE WERE MANY CLINICAL AND OTHER FACTORS INVOLVED IN THE PATIENT'S DEATH, HOWEVER NO FURTHER INFORMATION WAS PROVIDED DUE TO PATIENT'S CONFIDENTIALITY. GIVEN THE INFORMATION PRESENTED AT THIS TIME, IT IS INCONCLUSIVE THAT THE FREESTYLE LIBRE 2 DEVICE HAS LED TO OR CONTRIBUTED TO THE DEATH OF THE PATIENT. A FOLLOW UP WILL BE SENT IF FURTHER INFORMATION IS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1642936 | FREESTYLE LIBRE 2 | FLASH GLUCOSE MONITORING SYSTEM | QLG | ABBOTT DIABETES CARE INC | 71992-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |