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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 71953-01
Device Problems Failure to Power Up (1476); Unable to Obtain Readings (1516)
Patient Problems Hyperglycemia (1905); Tachycardia (2095); Loss of consciousness (2418)
Event Date 01/01/2024
Event Type  Injury  
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced anxiety, palpitation, hypertension, and a loss of consciousness.Customer was unable to self-treat and was treated with iv insulin (dose/type unspecified) for treatment of a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
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 customer¿s product has been requested for 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.Dhrs for the libre reader was reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The exact date of event is unknown.The date entered in section b3 is based on the customer report of "in january".In mdr all pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
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 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.At this time product has not yet been returned.An extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specification.The dhrs (device history review) for the libre reader were reviewed and the dhrs showed the libre reader passed all tests prior to release.In addition, the review determined that the correct cable and adapter were part of the reader kit pack and there was no indication that the product did not meet specifications.If the product is returned, a physical investigation will be performed and a follow-up report submitted.This serves as a correction report.Section (h10 - additional mfg narrative ) was incorrectly documented in the previous report.Correction has been done.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/no power issue was reported with the adc device.Customer was unable to test due to the device not powering on with button press or test strip insertion and as a result, experienced anxiety, palpitation, hypertension, and a loss of consciousness.Customer was unable to self-treat and was treated with iv insulin (dose/type unspecified) for treatment of a diagnosis of hyperglycemia.There was no report of death or permanent impairment associated with this event.
 
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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 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda 94502-7001
5107495297
MDR Report Key18956637
MDR Text Key338301872
Report Number2954323-2024-09600
Device Sequence Number1
Product Code QLG
UDI-Device Identifier05021791001040
UDI-Public(01)05021791001040(10)01C266F(91)71958-01
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K193371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/02/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2024
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? No
Date Manufacturer Received05/02/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/31/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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