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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 Problem Hyperglycemia (1905)
Event Date 02/18/2024
Event Type  Injury  
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 it has been determined that 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.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.
 
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 hyperglycemia symptoms.Customer was unable to self-treat and was treated with an insulin injection(dose/type unspecified) by a healthcare provider.No further treatment was reported.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader (b)(6) has been returned and investigated with a retained strip.Visual inspection was performed on the returned reader and no issues were observed.Reader did not powered on with button depression, strip or usb cable insertion.Reader was connected to pc and masterm, however did not recognize the reader.The returned reader was further investigated and de-cased.Visual inspection has been performed on the de-cased returned reader and no issues were observed.The returned battery voltage was measured.Reader was placed into the reader pcba (printed circuit board assembly) text fixture and pressure was applied to the cpu (central processing unit).The reader turned on and battery was observed to be charging.An extended investigation was performed on the reader.Visual inspection was performed on the returned reader and no issues were observed.The reader did not powered on with the button depression, strip or usb insertion.The reader did not charged and unable to recognized by the pc and masterm when connected.The reader was de-cased and visually inspected the pcba and damage usb port was observed.No other issues were observed with the internal components such as liquid contamination, missing components or a short between components and the pcba identified.The returned battery voltage was measured and not within specification range.The returned battery was replaced with known good battery and the reader powered on.It has been determined that the cause for the customer complaint was poor connection to pcba caused by damaged usb port, hence the reader battery did not charge.It was determined that the root cause is a poor connection between the usb port pins and the pcba.Although glucose results may be delayed, blood glucose could be determined by alternate means, including use of another blood glucose meter, seeing a physician (as recommended in product labeling), or by seeking treatment at a health care facility.Therefore, the issue is not confirmed to use.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 hyperglycemia symptoms.Customer was unable to self-treat and was treated with an insulin injection(dose/type unspecified) by a healthcare provider.No further treatment was reported.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 CA 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda, CA 94502-7001
5107495297
MDR Report Key18822823
MDR Text Key336733339
Report Number2954323-2024-07452
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUK
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 04/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/01/2024
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? Device Returned to Manufacturer
Date Manufacturer Received04/09/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/06/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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