MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE LIBRE 14 DAY; FLASH GLUCOSE MONITORING SYSTEM

Model Number 71938-01

Device Problem Low Readings (2460)

Patient Problems Nausea (1970); Polydipsia (2604)

Event Date 02/07/2024

Event Type  malfunction  

Manufacturer Narrative

The most probable root causes associated with this failure mode are disconnected, faulty or damaged components, software/data corruption, or misuse.However, mitigations are in place to reduce and prevent such issues.All vital manufacturing steps are validated, monitored, and verified during manufacturing to ensure the system is in conformance with the verified design.All vital functions are monitored by the system and, when necessary, function is suspended to safeguard against inaccurate results.Labeling is provided to instruct the user on the intended use of all vital parts of the system to minimize misuse.All complaints and complaint trends are investigated to determine if there is a product defect/ deficiency.If a product defect/ deficiency is identified, a risk evaluation is completed and compared to the risk management report, to ensure the risk profile has not changed.Additionally, as a part of abbott¿s post-market surveillance process, all risk evaluations with associated complaint data are reviewed annually to determine if the risk profiles have changed as compared to the product risk management reports.These monitoring processes ensure that all product risk profiles remain acceptable and have a positive benefit/ risk ratio.The product has been requested back for an investigation.At this time, product has not yet been returned and a valid serial number has not been provided for the strip.An 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 precision strips continue to be safe, effective, and perform as intended in the field.Stability data for precision strips 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 precision strips; no trends were identified that would indicate any product related issues.The dhrs (device history record) for the libre reader were reviewed, and the dhrs showed the libre 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.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving low readings from their adc device.A low reading of 210 mg/dl which was lower than a lab reading of 501 mg/dl.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.As a result, the customer experienced nausea and thirst.The customer was seen at a clinic wherein their blood glucose was checked (result unspecified), and was administered an unspecified injection by a healthcare professional (hcp).There was no report of death, serious injury, or mistreatment associated with this event.

Manufacturer Narrative

The reader (b)(6) has been returned and investigated with retained test strips.Visual inspection has been performed on the reader and no issues were observed.Control solution testing was performed, and all results were not satisfactory.The returned reader was further investigated and de-cased.Visual inspection has been performed and damaged component was observed.Extended investigation has been performed on the returned reader.Reader was de-cased and damage was observed, due to incorrect de-casing method.This damaged was due to de-casing as tracks of pcba (printed circuit board assembly) have been pulled away from pcba and not due to dropping from height.Strip port was inspected and observed damage to strip port opening which was consistent with misuse or attempted cleaning of the port.Contamination was also observed inside strip port.Therefore, issue is not confirmed to use.All pertinent information available to abbott diabetes care has been submitted.

Event Description

A customer reported receiving low readings from their adc device.A low reading of 210 mg/dl which was lower than a lab reading of 501 mg/dl.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.As a result, the customer experienced nausea and thirst.The customer was seen at a clinic wherein their blood glucose was checked (result unspecified), and was administered an unspecified injection by a healthcare professional (hcp).There was no report of death, serious injury, or mistreatment associated with this event.

• 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 Key: 18763902
• MDR Text Key: 336049435
• Report Number: 2954323-2024-06351
• Device Sequence Number: 1
• Product Code: PZE
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P160030
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 71938-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention