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

Model Number	70805-70
Medical Device Problem Codes	No Device Output (1435); Unable to Obtain Readings (1516)
Health Effect - Clinical Codes	Dehydration (1807); Diarrhea (1811); Hyperglycemia (1905); Pain (1994); Sweating (2444)
Date of Event	10/04/2020
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 performed for freestyle strips and all units performed within specification.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
A customer reported the blood glucose test would not start with test sample insertion, with the adc blood glucose meter.On (b)(6) 2020, the customer went to a walk-in clinic, but did not receive diabetes related treatment.The customer then began experiencing symptoms of dehydration, pain, diarrhea, and sweating, and self-presented at a hospital on (b)(6) 2020.The customer was diagnosed with hyperglycemia, and reported receiving unspecified treatment for dehydration and pain relievers.There was no report of death or permanent injury associated with this event.
Additional Manufacturer Narrative
Visual inspection performed on the returned meter and no issues were observed.The meter powered on with button depression and with strip insertion.All results were within range specification and no errors were observed during control solution testing.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 the blood glucose test would not start with test sample insertion, with the adc blood glucose meter.On (b)(6)2020, the customer went to a walk-in clinic, but did not receive diabetes related treatment.The customer then began experiencing symptoms of dehydration, pain, diarrhea, and sweating, and self-presented at a hospital on (b)(6)2020.The customer was diagnosed with hyperglycemia, and reported receiving unspecified treatment for dehydration and pain relievers.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: 10907103
• Report Number: 2954323-2020-11968
• Device Sequence Number: 14204514
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 03/04/2021

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: 05/31/2022
• Device Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1126342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2021
• Initial Date Received by Manufacturer: 11/05/2020
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 03/04/2021
• 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: 68 YR
• Patient Weight: 89