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

Model Number	75175-83
Medical Device Problem Codes	Unable to Obtain Readings (1516); Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Hyperglycemia (1905); Loss of consciousness (2418)
Date of Event	10/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an 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
Customer's husband reported being unable to test due to receiving an error 7 on the display of his wife's adc blood glucose meter.Customer experienced loss of consciousness due to hyperglycemia and received unspecified third party treatment.No further information was provided as the caller refused to continue troubleshooting.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
No product has been returned and an extended investigation has been performed for the reported complaint.There was no indication that the product did not meet specifications.The dhrs (device history review) for the fs precision neo meter and precision strips were reviewed.The dhrs showed the fs precision neo meter and precision strips passed all tests prior to release.Retain testing was performed and all units performed within specification.If the product is returned, the case will be re-opened, and a physical investigation will be performed.
Event or Problem Description
Customer's husband reported being unable to test due to receiving an error 7 on the display of his wife's adc blood glucose meter.Customer experienced loss of consciousness due to hyperglycemia and received unspecified third party treatment.No further information was provided as the caller refused to continue troubleshooting.There was no report of death or permanent injury 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: 10816351
• Report Number: 2954323-2020-10200
• Device Sequence Number: 14474781
• Product Code: NBW
• UDI-Device Identifier: 00093815715795
• UDI-Public: 00093815715795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K140371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2020

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 Expiration Date: 11/30/2020
• Device Model Number: 75175-83
• Device Catalogue Number: 71579
• Device Lot Number: 4500182285
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/04/2020
• 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