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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 Product Quality Problem (1506)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/29/2024
Event Type  malfunction  
Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
Customer initially reported their adc device displayed a low battery icon.The product was returned and investigated for a low battery icon, however during investigation a burned component was observed on the reader¿s printed circuit board assembly (pcba).This report is being submitted due to the additional issue observed during returned product investigation.
 
Manufacturer Narrative
This serves as a correction report.Section b-3 (date of event) and g-3 (date received by mfg) were incorrectly documented in the previous initial report.Section b-3 has been updated.The correct g-3 date is (b)(6) 2024.
 
Event Description
Customer initially reported their adc device displayed a low battery icon.The product was returned and investigated for a low battery icon, however during investigation a burned component was observed on the reader¿s printed circuit board assembly (pcba).This report is being submitted due to the additional issue observed during returned product 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 94502 7001
Manufacturer Contact
audra fuentes
1360 south loop road
alameda 94502-7001
5107495297
MDR Report Key19066456
MDR Text Key339665344
Report Number2954323-2024-11865
Device Sequence Number1
Product Code QLG
UDI-Device Identifier05021791001668
UDI-Public(01)05021791001668(10)02C285F(91)71960-01
Combination Product (y/n)N
Reporter Country CodeFR
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 04/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number71953-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/22/2023
Date Manufacturer Received06/03/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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