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 Code	Hyperglycemia (1905)
Date of Event	12/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, product has not yet been returned.An extended investigation has been performed for the reported complaint, and it has been determined that there was no indication that the product did not meet specification.The dhrs (device history record) for the freestyle lite meter and freestyle strips were reviewed, and the dhrs showed the freestyle lite meter and freestyle strips passed all tests prior to release.Retain testing was not performed for freestyle strips as the test strips expired on 31 aug 2020.If the product is returned, a physical investigation will be performed and a follow-up report submitted.The date the incident occurred is unknown.The date entered is 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 a delivery delay with a replacement adc blood glucose meter.The replacement device was issued as customer had reported low glucose results.Due to delivery delay, customer reported being hospitalized due to high blood glucose as she had no method to monitor glucose.The customer did not provide treatment information but did state she was prescribed insulin after hospitalization.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
The reported meter has been returned and investigated.Visual inspection has been performed on the meter no issues were observed.Meter powered on with button and retained test strips.Control solution testing has been performed and 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
A customer reported a delivery delay with a replacement adc blood glucose meter.The replacement device was issued as customer had reported low glucose results.Due to delivery delay, customer reported being hospitalized due to high blood glucose as she had no method to monitor glucose.The customer did not provide treatment information but did state she was prescribed insulin after hospitalization.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
• Manufacturer Contact: audra fuentes ; 1360 south loop road; alameda, CA 94502-7001 ; 5107495297
• MDR Report Key: 13213604
• Report Number: 2954323-2022-01045
• Device Sequence Number: 4745109
• Product Code: NBW
• UDI-Device Identifier: 00699073708274
• UDI-Public: 00699073708274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/01/2022

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: 08/31/2020
• Device Model Number: 70805-70
• Device Catalogue Number: 70827
• Device Lot Number: 1061979
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2021
• Supplement Date Received by Manufacturer: 02/21/2022
• Initial Report FDA Received Date: 01/10/2022
• Supplement Report FDA Received Date: 03/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2018
• 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; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: American Indian Or Alaskan Native