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

Model Number	75175-84
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	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No product has been returned, extended investigation is pending at this time.A follow- up report will be submitted once additional information is obtained.The device manufacturer date for the reported meter is unknown.The date entered is the date abbott diabetes care became aware of the event.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 44 mg/dl and 302 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
No product has been returned and a valid serial number has not been provided for the reader.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 precision strips was reviewed and the dhrs showed the precision strips passed all tests prior to release.Retain testing could not be performed for the precision strips indicated by the serial number provided by the customer as the precision strips was expired on (b)(6) 2020.A tripped trend review was conducted for the reported complaint and the freestyle precision neo meter, 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.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.Therefore, section d4 was updated to unk.
Event or Problem Description
Customer reported receiving erratic readings on their adc blood glucose meter.Customer reported receiving readings of 44 mg/dl and 302 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.

• Brand Name: FREESTYLE PRECISION NEO
• Common Device Name: BLOOD GLUCOSE MONITORING SYSTEM
• Manufacturer (Section D): ABBOTT DIABETES CARE INC; 1360 south loop road; alameda CA 94502 7001
• MDR Report Key: 12009626
• Report Number: 2954323-2021-72545
• Device Sequence Number: 17194232
• Product Code: NBW
• UDI-Device Identifier: 00093815715795
• UDI-Public: 00093815715795
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K142928
• 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
• Report Date (Section B): 06/21/2021

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 Model Number: 75175-84
• Device Catalogue Number: 71579
• Device Lot Number: 4500181669
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 06/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 100