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

Model Number	70805-70
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Codes	Hypoglycemia (1912); Muscle Weakness/Atrophy (1967); Loss of consciousness (2418); Diaphoresis (2452); Convulsion/Seizure (4406)
Date of Event	06/01/2021
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 there was no indication that the product did not meet specification.Extended investigation concludes that freestyle strips are isolated to the meter only.For meters using freestyle strips, when the strip is inserted, the no-touch pin is pushed upwards and makes contact with the ground pin to power the meter on.Only the displacement of the pin powers on the meter, rather than carbon traces on the strip.The only function of the strip is to facilitate the movement of the pin, therefore, no strip-related investigation activities are performed.Dhrs (device history record) for the freestyle lite meter were reviewed and the dhrs showed the libre reader passed all tests prior to release.If the product is returned, a physical investigation will be performed.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported being unable to test due to the adc blood glucose meter turning on with button press but not with test strip insertion.Customer experienced symptoms described as "sweating, chills, inability to speak, inability to move, difficulty swallowing, weakness, seizure and a loss of consciousness".Customer had contact with healthcare provider who diagnosed him with hypoglycemia and treated with unspecified iv to increase the blood glucose.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: 12101245
• Report Number: 2954323-2021-74496
• Device Sequence Number: 4169463
• Product Code: NBW
• UDI-Device Identifier: 00699073710260
• UDI-Public: 00699073710260
• Combination Product (Y/N): N
• Initial Reporter State: PR
• 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): 07/01/2021

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: 07/31/2021
• Device Model Number: 70805-70
• Device Catalogue Number: 71026
• Device Lot Number: 1099273
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2021
• Initial Report FDA Received Date: 07/01/2021
• 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 Weight: 79