MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	71411-70
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	03/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for investigation and the customer agreed to return the device.A follow-up report will be submitted upon completion of investigation activities or if additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A low reading issue was reported with the abbott diabetes care (adc) device.A healthcare professional reported unspecified incorrect readings received on the adc device.On (b)(6)2025 at 09:55am, the customer had a reading of 40 mg/dl using a laboratory analyzer.At 10:59am and 11:02am, they obtained a blood glucose reading of less than 20 mg/dl using the adc meter.The customer did not experience any symptoms but was treated with 5% dextrose administered intravenously by a healthcare professional.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The returned meter (b)(6) was investigated with a known-good retained battery.Visual inspection was performed on returned meter and spm (strip port module); no issues were observed.Installed retain batteries into the meter.Meter powered on with button depression.No issues were observed with the lcd during power up and self-test sequence.Control solution testing has been performed and all results were within specification range.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.At this time freestyle strip 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 freestyle strips continue to be safe, effective, and perform as intended in the field.Stability data for freestyle strips was reviewed and showed no anomalies or non-conformances that could have lead to the complaint.The available tracking and trending reports were conducted for the reported complaint and freestyle strip, no trends were identified that would indicate any product related issues.Dhrs (device history review) for the freestyle precision pro meter was reviewed and the dhrs showed the freestyle precision pro meter met specifications prior to release to distribution.Dhrs (device history review) for the strip port module was reviewed and the dhrs showed the strip port module met specifications prior to release to distribution.This also serves as a correction report.Section h4 (device mfg date) was incorrectly documented in the previous report.Correction has been made.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A low reading issue was reported with the abbott diabetes care (adc) device.A healthcare professional reported unspecified incorrect readings received on the adc device.On (b)(6) 2025 at 09:55am, the customer had a reading of 40 mg/dl using a laboratory analyzer.At 10:59am and 11:02am, they obtained a blood glucose reading of less than 20 mg/dl using the adc meter.The customer did not experience any symptoms, but was treated with 5% dextrose administered intravenously by a healthcare professional.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE PRECISION PRO
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• Manufacturer Contact: patricia reis castro ; 1360 south loop road; alameda, CA 94502-7001 ; 4157205405
• MDR Report Key: 21787027
• Report Number: 2954323-2025-12263
• Device Sequence Number: 8610977
• Product Code: NBW
• UDI-Device Identifier: 00357599807009
• UDI-Public: (01)00357599807009(10)01C164D
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K132511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2025

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
• Operator of Device: Lay User/Patient
• Device Model Number: 71411-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2025
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 04/07/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown