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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 Problem Loss of consciousness (2418)
Event Date 12/05/2023
Event Type  Injury  
Event Description
A battery/power issue was reported with the adc device.The customer was unable to obtain readings due to a fast-draining battery.As a result, the customer experienced a loss of consciousness, and an unspecified third-party treatment was provided.The customer reported an hcp reading was obtained; however, no values were provided.No further treatment was required.There was no report of death or permanent impairment associated with this event.
 
Manufacturer Narrative
The product has been requested back for an 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 freestyle libre reader were reviewed and the dhrs showed the freestyle 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 date of event is unknown.The date entered in section b3 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
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.Reader (b)(6) has been returned and investigated.Visual inspection has been performed on the returned reader and no issues were observed.Reader was sufficiently charged.The reader was de-cased for further inspection and no contamination, corrosion, or damage was observed on the printed circuit board.Power consumption test performed and was within specifications.No malfunction or product deficiency has been identified.Therefore, issue is not confirmed due to fast draining battery not observed.If partial 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 also serves as a correction report.Section h10 (additional mfg narrative) was incorrectly updated in the initial report.Correction has been made.
 
Event Description
A battery/power issue was reported with the adc device.The customer was unable to obtain readings due to a fast-draining battery.As a result, the customer experienced a loss of consciousness, and an unspecified third-party treatment was provided.The customer reported an hcp reading was obtained; however, no values were provided.No further treatment was required.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 Key18360946
MDR Text Key330930248
Report Number2954323-2023-54512
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 02/26/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2023
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 Manufacturer Received02/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/19/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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