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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 Problem Premature Discharge of Battery (1057)
Patient Problems Hypoglycemia (1912); Loss of consciousness (2418)
Event Date 03/01/2022
Event Type  Injury  
Event Description
A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced hypoglycemia and a loss of consciousness.It was additionally reported by a third party that the customer was found on the floor lying, groaning, not talking, and was not themselves.Paramedics were contacted and a blood glucose result of 23 mg/dl was obtained on unspecified device.The customer was treated with glucose injection and provided orange juice and food.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
Reader megb301-j4778 has been returned and is currently undergoing investigation process.A follow up report will be submitted once all investigation activities are complete.The date of event is unknown.The date entered in section b3 is per the caller's report of (b)(6) 2022.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Reader (b)(6) was returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader was sufficiently charged.Visually inspected the usb/charging cable and no issues were observed.No opens or shorts were observed.Usb/charging cable passed testing.Visually inspected the power adapter and no issues were observed.All results were within specification.Power adapter passed testing.The returned reader was de-cased and no issues were observed upon visual inspection.Performed power consumption test.All results were within specification.Therefore, this issue is not confirmed due to fast draining battery not observed.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 and kit pack for verification of correct cable and adapter was reviewed.The dhrs showed the libre reader passed all tests prior to release and correct cable and adapter was part of the kit pack.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A battery/power issue was reported with the adc device.Customer was unable to obtain readings due to a fast draining battery.As a result, customer experienced hypoglycemia and a loss of consciousness.It was additionally reported by a third party that the customer was found on the floor lying, groaning, not talking, and was not themselves.Paramedics were contacted and a blood glucose result of 23 mg/dl was obtained on unspecified device.The customer was treated with glucose injection and provided orange juice and food.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 Key16855879
MDR Text Key314410076
Report Number2954323-2023-16782
Device Sequence Number1
Product Code QLG
Combination Product (y/n)N
Reporter Country CodeUS
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 06/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/02/2023
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 Returned to Manufacturer04/26/2023
Date Manufacturer Received05/15/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient SexFemale
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