MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE PRECISION PRO; 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	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s product has been requested for investigation.A follow-up report will be filed once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A health care professional reported erratic readings from an adc device.The health care professional reported readings of "lo" (below 20 mg/dl) and 380 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Event or Problem Description
A health care professional reported erratic readings from an adc device.The health care professional reported readings of "lo" (below 20 mg/dl) and 380 mg/dl within 10 minutes.The results when plotted on a parkes error grid fell into the "c" zone showing the difference in values to be clinically significant.There was no report of death, serious injury, or mistreatment associated with this event.
Additional Manufacturer Narrative
The returned meter was investigated with retained test strips and a known-good retained battery.Visual inspection has been performed on returned meter and no issues were observed.Installed retained batteries.Meter turns on with button depression.Lcd (liquide crystal display) was observed during power up/ self-test sequence and no issues were observed.Control solution testing has been performed and all results were within range specification.No malfunction or product deficiency was identified.Therefore, issue is not confirmed.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 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 review) for the freestyle precision xceed pro meter was reviewed and the dhrs showed the freestyle precision xceed pro meter passed all tests prior to release.If the strips were 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.Upon extended investigation, it was determined that the strip lot number provided by the customer (4m335h) and previously reported to the fda was not a valid lot number.Therefore, section d4 - lot # was updated to unk.

• 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: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 17765115
• Report Number: 2954323-2023-41026
• Device Sequence Number: 7010650
• Product Code: NBW
• UDI-Device Identifier: 00093815709329
• UDI-Public: 00093815709329
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

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: Health Professional
• 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: 08/29/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2023
• 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
• Patient Sex: Unknown