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	Insufficient Information (4580)
Date of Event	08/30/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
At this time product has not yet been returned.An 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 freestyle lite meter were reviewed.The dhrs showed the freestyle lite meter passed all tests prior to release.Dhrs (device history review) for the freestyle strips were reviewed.The dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed for the freestyle strips and all units performed in the specification and passed.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.
Event or Problem Description
Customer reported receiving erratic readings with their adc blood glucose meter.Customer reported receiving readings of 19 mg/dl and 159 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
Meter (b)(6) has been returned and investigated with returned test strips.Visual inspection has been performed on the returned meter and no issues were observed.Meter powered on with button and with strip insertion.Meter advanced to the "apply sample" screen when a test strip was inserted.Control solution testing was performed and no issues were observed.All results were within range specification.No malfunction or product deficiency was identified.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported receiving erratic readings with their adc blood glucose meter.Customer reported receiving readings of 19 mg/dl and 159 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 LITE
• 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: 12529796
• Report Number: 2954323-2021-85840
• Device Sequence Number: 4291338
• Product Code: NBW
• UDI-Device Identifier: 00699073710260
• UDI-Public: 00699073710260
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 09/28/2021

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 Expiration Date: 11/30/2022
• Device Model Number: 70805-70
• Device Catalogue Number: 71026
• Device Lot Number: 1140140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2021
• Initial Date Received by Manufacturer: 08/30/2021
• Supplement Date Received by Manufacturer: 09/27/2021
• Initial Report FDA Received Date: 09/24/2021
• Supplement Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 78