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

Model Number	70914-70
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2021
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 determined that there was no indication that the product did not meet specification.The dhrs showed the freestyle lite test strips and freestyle lite meter passed all tests prior to release.Dhrs for the freestyle freedom lite meter was reviewed and the dhrs showed the freestyle freedom lite meter passed all tests prior to release.Retain testing was performed for freestyle strips and all units performed in 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
A high readings issue was reported with the use of the adc glucose meter.The customer reported receiving a ¿hi¿ (readings greater than 500 mg/dl) message and a 415 mg/dl scan on the sensor.The customer became light-headed and he contacted his doctor who advised him to go to the er.At the er, a reading of 390 mg/dl was obtained on the hcp meter and an unspecified iv drip was administered as treatment.The customer was monitored in the er for 5 hours and no additional treatment was reported.There was no report of death or permanent injury associated with this event.

• Brand Name: FREESTYLE FREEDOM 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: 11606220
• Report Number: 2954323-2021-65315
• Device Sequence Number: 14333021
• Product Code: NBW
• UDI-Device Identifier: 00699073710260
• UDI-Public: 00699073710260
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 04/01/2021

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: 07/31/2022
• Device Model Number: 70914-70
• Device Catalogue Number: 71026
• Device Lot Number: 1130562
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2021
• Initial Report FDA Received Date: 04/01/2021
• 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: 71 YR
• Patient Weight: 109