MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 2; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71953-01

Device Problem No Device Output (1435)

Patient Problems Hyperglycemia (1905); Dizziness (2194); Loss of consciousness (2418); Cognitive Changes (2551); Convulsion/Seizure (4406)

Event Date 06/24/2023

Event Type  Injury  

Manufacturer Narrative

The product has been requested back for an investigation.A follow-up report will be submitted, once additional information is obtained.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.

Event Description

A testing issue was reported, with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied.And customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, "noise", "dizziness".And was able to self-treat with insulin (type/dose unspecified).There was no report of death or permanent injury associated with this 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.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.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.The device mfg 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.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.

Event Description

A testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, "noise", "dizziness", and was able to self-treat with insulin (type/dose unspecified).There was no report of death or permanent injury associated with this 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.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.A tripped trend review was conducted for the reported complaint and libre reader, 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.The device mfg 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.This serves as a correction report.Section h10 (addtl mfg narrative) was incorrectly documented in the previous report.The correction has been made here.

Event Description

A testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, "noise", "dizziness", and was able to self-treat with insulin (type/dose unspecified).There was no report of death or permanent injury associated with this event.

Manufacturer Narrative

Additional information: updated sn: serial number changed from unk to (b)(6)manufacturing date: update to 03/12/2022 reader (b)(6) has been returned and investigated with retained strip.Performed a visual inspection on the returned reader and no issues were observed.The returned reader powered on with button and with insertion strip of retained strips.An error was observed when control solution testing was performed.The returned reader was sent to further investigation and de-cased.Upon visual inspection of the de-cased readers' printed circuit board assembly (pcba), observed poor solder joint on the reader strip port pins.Applied pressure and re-flowed the strip port pins and errors were no longer observed.Therefore, this issue is confirmed to poor solder on strip port pins.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A dhr (device history review) for the fs libre reader was reviewed and the dhr showed the fs libre reader passed all tests prior to release.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A testing issue was reported with the abbott diabetes care (adc) reader.The test did not start after the blood sample was applied and customer was unable to obtain readings.As a result, customer experienced a loss of consciousness, seizure, "noise", "dizziness", and was able to self-treat with insulin (type/dose unspecified).There was no report of death or permanent injury associated with this event.

• 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 Key: 17246365
• MDR Text Key: 318276635
• Report Number: 2954323-2023-28554
• Device Sequence Number: 1
• Product Code: QLG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K193371
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 71953-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 06/24/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 10/19/2023; 12/06/2023; 01/31/2024
• Supplement Dates FDA Received: 11/03/2023; 12/06/2023; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other