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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 No Device Output (1435); Unable to Obtain Readings (1516)
Patient Problems Fatigue (1849); Hyperglycemia (1905); Vomiting (2144)
Event Date 10/04/2023
Event Type  Injury  
Event Description
A testing issue was reported with the adc device.The customer reported the test did not start after the blood sample was applied and he was unable to obtain readings.As a result, customer experienced symptoms of fatigue, vomiting, dehydration, and was unable to self-treat.Customer had contact with a healthcare professional at the hospital who provided 14 units of insulin infusion as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A testing issue was reported with the adc device.The customer reported the test did not start after the blood sample was applied and he was unable to obtain readings.As a result, customer experienced symptoms of fatigue, vomiting, dehydration, and was unable to self-treat.Customer had contact with a healthcare professional at the hospital who provided 14 units of insulin infusion as treatment for the diagnosis of hyperglycemia.There was no report of death or permanent injury associated with this event.
 
Manufacturer Narrative
Additional information: section d4 (serial no) & (udi) were updated based on the returned product.Reader (b)(6) was returned and investigated with retained strip.Performed a visual inspection on the returned reader and no issue was observed.The returned reader powered on with button depression and with insertion of retained strips.A control solution test was performed, and the returned reader did not start after the sample was applied.The meter was sent for further investigation and de-cased.Upon visual inspection of the de-cased readers¿ printed circuit board assembly (pcba), and poor solder joint on the reader strip port pins which prevented the customer from performing glucose strip test.Applied pressure and re-flowed solder on the strip port pins, observed control solution test passed.Therefore, this issue is confirmed to poor solder on strip port pins.An extended investigation has been performed for the reported complaint and 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.All pertinent information available to abbott diabetes care has been submitted.
 
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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 Key17967184
MDR Text Key326071857
Report Number2954323-2023-46622
Device Sequence Number1
Product Code QLG
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 01/31/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/19/2023
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 Received01/21/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/28/2022
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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