MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC FREESTYLE FREEDOM LITE; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	70914-71
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	Loss of consciousness (2418)
Date of Event	12/13/2021
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.The date entered is per the customer report of "last monday evening", from 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
A customer reported an "error 3" message with the adc blood glucose meter, when applying blood sample to test strip.The customer was therefore unable to obtain glucose result, and experienced a loss of consciousness.The customer reported requiring treatment from a healthcare provider, but declined to provide further details.Please note that upon troubleshooting it was found that customer was applying blood sample to incorrect position on test strip.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Repeated attempts by adc to retrieve the product were unsuccessful and/or the customer discarded the product.No product has been returned as of this report.Extended investigation has been performed for the reported complaint and there was no indication that the product did not meet specification.A dhr (device history review) for the freestyle freedom lite meter was reviewed and the dhr showed the freestyle freedom lite meter passed all tests prior to release.A dhr (device history review) for the freestyle strips was reviewed and the dhr showed the freestyle strips passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed in specification and passed.If the product is returned, the case will be re-opened, and a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A customer reported an "error 3" message with the adc blood glucose meter, when applying blood sample to test strip.The customer was therefore unable to obtain glucose result, and experienced a loss of consciousness.The customer reported requiring treatment from a healthcare provider, but declined to provide further details.Please note that upon troubleshooting it was found that customer was applying blood sample to incorrect position on test strip.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE FREEDOM LITE
• 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: 13195364
• Report Number: 2954323-2022-00914
• Device Sequence Number: 17653964
• Product Code: NBW
• UDI-Device Identifier: 00699073708274
• UDI-Public: 00699073708274
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• 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): 01/26/2022

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: 04/30/2020
• Device Model Number: 70914-71
• Device Catalogue Number: 70827
• Device Lot Number: 1050667
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2021
• Supplement Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 01/07/2022
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2017
• 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: Female