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

Model Number	70805-70
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Hyperglycemia (1905); Nausea (1970)
Date of Event	10/27/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The meter was returned and investigated with returned/retained test strips.The complaint was not confirmed and no new issues were observed.All results were within the range specification and no errors were observed during control solution testing.Additionally, the reported reading of 122 mg/dl was found in the meter's internal memory log, however not on the reported date of incident.An extended investigation is pending.A follow-up report will be submitted once investigation is complete.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
A low readings issue was reported with the adc meter.Customer reported experiencing nausea and having contact with an hcp who obtained a reading of 168 mg/dl on their device compared to a sensor scan result of 122 mg/dl.Customer was diagnosed with hyperglycemia and administered intravenous fluids for treatment.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Extended investigation has been performed.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.Dhrs (device history review) for the freestyle test strips were reviewed and the dhrs showed the freestyle test strips passed all tests prior to release.Retain testing was performed for the freestyle strips and all units performed within specification.If the reported test strips are returned, an investigation will be completed.
Event or Problem Description
A low readings issue was reported with the adc meter.Customer reported experiencing nausea and having contact with an hcp who obtained a reading of 168 mg/dl on their device compared to a sensor scan result of 122 mg/dl.Customer was diagnosed with hyperglycemia and administered intravenous fluids for treatment.There was no report of death or permanent injury 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: 10901023
• Report Number: 2954323-2020-11822
• Device Sequence Number: 546175
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K092602
• 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): 12/16/2020

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 Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1131837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/16/2020
• 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
• Patient Age: 56 YR
• Patient Weight: 54