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

Model Number	71411-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/10/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product has been requested back for 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 or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Meter (b)(6)has been returned and investigated.Visual inspection has been performed on returned meter and a crack was observed on meter casing.A qual-6 issue was cloned to address the issue.Installed retained batteries.Meter powered on with button depression.Lcd (liquid crystal display) was observed during power up and self-test sequence, no issues observed.Control solution testing has been performed and all results were within range specification.Therefore, this issue is not confirmed.If the reported strips are returned, a physical investigation will be performed, and a follow-up report will be submitted.All pertinent information available to abbott diabetes care has been submitted.This serves as a correction report.
Event or Problem Description
A customer reported receiving erroneous glucose results from an abbott diabetes care device.The results when plotted on a parkes error grid fell into either the c, d, or e zone.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
Meter (b)(6) has been returned and investigated.Visual inspection has been performed on returned meter and a crack was observed on meter casing.A qual-6 issue was cloned to address the issue.Installed retained batteries.Meter powered on with button depression.Lcd (liquid crystal display) was observed during power up and self-test sequence, no issues observed.Control solution testing has been performed and all results were within range specification.Therefore, this 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 (device history review) for the freestyle precision xceed pro 1.10 meter was reviewed and the dhrs showed the freestyle precision xceed pro 1.10 meter passed all tests prior to release.Dhrs (device history review) for the precision strips was reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing was performed for precision strips and all units performed in specification and passed.If the reported strips are returned, a physical investigation will be performed, and a follow-up report will be submitted.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.Correction has been done.

• Brand Name: PRECISION XCEED PRO METER
• Common Device Name: BLOOD 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: 16271263
• Report Number: 2954323-2023-04774
• Device Sequence Number: 14933816
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: 00093815709329
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080960
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/31/2023
• Device Model Number: 71411-70
• Device Catalogue Number: 70932
• Device Lot Number: 4K915H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/10/2023
• Supplement Date Received by Manufacturer: 08/31/2023; 03/01/2024
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 09/19/2023; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/26/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown