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

Model Number	70805-70
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	02/19/2024
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
Customer reported receiving a high reading from their adc device.Customer reported a high reading of 219 mg/dl which was higher than a lab reading of 95 mg/dl.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
Customer reported receiving a high reading from their adc device.Customer reported a high reading of 219 mg/dl which was higher than a lab reading of 95 mg/dl.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 reported meter and strips has been returned and investigated with known-good retained battery.Visual inspection has been performed on the returned meter and strips; no issues were observed.Meter powered on with button depression and strip insertion.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.There was no indication that the product did not meet specification.The dhrs (device history review) for the freestyle lite meter were reviewed and the dhrs showed the freestyle lite meter passed all tests prior to release.The dhrs (device history review) for the freestyle strips were reviewed and the dhrs 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.Section d4 (serial number) was updated from dcga125-n794 to dcga125-n0794.All pertinent information available to abbott diabetes care has been submitted.

• Brand Name: FREESTYLE 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: 18874950
• Report Number: 2954323-2024-08201
• Device Sequence Number: 9049653
• Product Code: NBW
• UDI-Device Identifier: 00699073708274
• UDI-Public: 00699073708274
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 03/22/2024

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: 09/30/2025
• Device Model Number: 70805-70
• Device Lot Number: 1212805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2024
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 03/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/04/2020
• 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