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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM
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ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71992-01
Device Problem Device Alarm System (1012)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 12/16/2020
Event Type  Injury  
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The date of event 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.
 
Event Description
An alarm issue was reported with the adc freestyle libre 2 sensor.Caller reported the low glucose alarm did not sound and customer experienced a loss of consciousness.Customer received unspecified "emergency injection".There was no report of death or permanent injury associated with this event.
 
Event Description
An alarm issue was reported with the adc freestyle libre 2 sensor.Caller reported the low glucose alarm did not sound and customer experienced a loss of consciousness.Customer received unspecified "emergency injection".There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Adc product quality engineering (pqe) investigated this alarm-3 (missing high or low glucose) complaint.It was determined that the freestyle libre 2 sensor reported in this complaint was manufactured at flex buffalo grove (fbg) with the incorrect low-temperature ratio parameter of zero (0).The low-temperature ratio parameter setting should be set at 187.The incorrect low-temperature ratio parameter will prevent the sensor bluetooth low-energy (ble) radio from enabling in the operational temperature range, and as a result, the system will not be able to present glucose alarms.This failure mode was identified during the investigation of the track and trend review related to alarm-3 cases in april 2020.This issue was addressed in the field by adc fa1027-2020.Dhrs (device history review) for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.The temperature ratio setting is in the machine software and therefore, not captured in the dhr.If the product is returned, a physical investigation will be performed and a follow-up report submitted.¿ adc quality hold qh1027-2020 rev01 was initiated on (b)(6) 2020 to all sites within adc control to prevent further distribution of the impacted sku.¿ qr728102 was initiated to investigate and address this issue on 16-may-2020.Immediate as well as corrective and preventative actions include: o software on affected kit pack lines has been updated to prevent the resetting of the low-temperature parameter to ¿0¿.This action was completed on 28-may-20.O impacted product within manufacturing control was determined to either be immediately scrapped or reworked.Rework and a scrap of impacted product is currently in process, with an anticipated completion of 31-jan-21 oupdate packaging line test limits and associated packaging line validation protocols to include applicable product software parameters for verification.This will ensure that the validation of additional packaging lines will include all the appropriate parameters for successful verification and validation.The completion date of this corrective action was 11-dec-20.O update validation process to include requirements to perform functional testing of the product to user requirement specifications.The anticipated completion date of this corrective action is 28-feb-21.¿ quality directive qd1002-2020 and faq¿s were issued to the field on 19-may-2020 to advise customer support of adc fa1027-2020, and how to handle customer calls related to the issue in impacted countries.¿ technical bulletin tb1008-2020 was issued to the field on 20-may-2020 to advise customer support of adc fa1027-2020, and how to handle customer calls related to the issue in non-impacted countries.¿ risk evaluation re1027-2020 was completed on 21-may-2020 to address the risk to the user as a result of this issue ¿ field action adc fa1027-2020 was issued to austria, germany, switzerland on 21-may-2020.
 
Event Description
An alarm issue was reported with the adc freestyle libre 2 sensor.Caller reported the low glucose alarm did not sound and customer experienced a loss of consciousness.Customer received unspecified "emergency injection".There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
No product has been returned.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit 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.This serves as a correction report.After further review, it has been determined that the reported serial number (b)(6) does not fall under adc fa1027-2020 as previously reported in the initial and follow up #1 reports.Sections h-6 and h-10 have been updated based on the corrected extended investigation.
 
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Brand Name
FREESTYLE LIBRE 2
Type of Device
FLASH GLUCOSE MONITORING SYSTEM
Manufacturer (Section D)
ABBOTT DIABETES CARE INC
1360 south loop road
alameda CA 94502 7001
MDR Report Key11067936
MDR Text Key223603128
Report Number2954323-2020-14369
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Remedial Action Other
Type of Report Initial,Followup,Followup
Report Date 04/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date03/31/2022
Device Model Number71992-01
Was Device Available for Evaluation? No
Date Manufacturer Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberQR728102
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age70 YR
Patient Weight60
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