Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM Back to Search Results
Model Number 71940-01
Device Problem Low Readings (2460)
Patient Problems Fatigue (1849); Headache (1880); Hyperglycemia (1905); Vomiting (2144)
Event Date 04/26/2023
Event Type  Injury  
Event Description
A customer reported a low reading with the adc device.The customer obtained an unspecified low sensor scan result compared to an unspecified result obtained from an hcp meter.As a result, the customer experienced symptoms of vomiting, weakness, and headache and received "insulin, injection test, and pump" as treatment by a healthcare professional.The customer further reported having contact with a non-healthcare provider.No further details were provided.There was no report of death or permanent impairment associated with this event.Sensor scan of 60 mg/dl were compared to 170 mg/dl respectively on the hcp meter, when plotted on a parkes error grid fell into the "c" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
 
Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.The device manufacturing date is unknown.The date entered in section h4 is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
 
Manufacturer Narrative
Sensor (b)(6) has been returned and investigated.The sensor plug is fully seated and no issues were observed.Extracted data from the returned sensor using approved software.The sensor was found to be in sensor state 5 (indicating normal termination).Inspected the plug assembly, no issues were observed.The current was applied to the sensor to perform accuracy testing while in the test fixture.All results were within specification.Poise voltage and sensor thermistor testing were both within specification, indicating the sensor was providing accurate glucose readings.No malfunction or product deficiency was identified.Therefore, the issue is not confirmed.An extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Dhrs for the fs libre sensor and fs libre sensor kit were reviewed and the dhrs showed the fs libre sensor and sensor kit passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.
 
Event Description
A customer reported a low reading with the adc device.The customer obtained an unspecified low sensor scan result compared to an unspecified result obtained from an hcp meter.As a result, the customer experienced symptoms of vomiting, weakness, and headache and received "insulin, injection test, and pump" as treatment by a healthcare professional.The customer further reported having contact with a non-healthcare provider.No further details were provided.There was no report of death or permanent impairment associated with this event.Sensor scan of 60 mg/dl were compared to 170 mg/dl respectively on the hcp meter, when plotted on a parkes error grid fell into the "c" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
 
Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned and a valid serial number has not been provided.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.Clinical data was reviewed and confirmed that libre sensors continue to be safe, effective, and perform as intended in the field.Stability data for libre sensors was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.A tripped trend review was conducted for the reported complaint and fs libre sensors, no trends were identified that would indicate any product related issues.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.Upon extended investigation, it was determined that the serial number provided by the customer ((b)(6)) and previously reported to the fda was not a valid serial number.Therefore, section d4 was updated to unk.
 
Event Description
A customer reported a low reading with the adc device.The customer obtained an unspecified low sensor scan result compared to an unspecified result obtained from an hcp meter.As a result, the customer experienced symptoms of vomiting, weakness, and headache and received "insulin, injection test, and pump" as treatment by a healthcare professional.The customer further reported having contact with a non-healthcare provider.No further details were provided.There was no report of death or permanent impairment associated with this event.Sensor scan of 60 mg/dl were compared to 170 mg/dl respectively on the hcp meter, when plotted on a parkes error grid fell into the "c" zone, showing the difference in values to be clinically significant.It is unknown when these readings were obtained in relation to the reported adverse event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
FREESTYLE LIBRE 14 DAY
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 Key17014864
MDR Text Key316089915
Report Number2954323-2023-22099
Device Sequence Number1
Product Code PZE
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
P160030
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,Followup
Report Date 09/11/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/26/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date07/31/2023
Device Model Number71940-01
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Manufacturer Received08/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/14/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-