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

Model Number	70805-70
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Codes	Hypoglycemia (1912); Loss of consciousness (2418); Confusion/ Disorientation (2553)
Date of Event	10/19/2020
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 review) for the freestyle meter were reviewed and the dhrs showed the freestyle meter passed all tests prior to release.The dhrs (device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.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
The wife of a customer reported he obtained a higher reading than how he felt when testing on the adc blood glucose meter, on (b)(6) -2020.As a result of the high glucose test, the customer self-treated with insulin (dose unknown), and subsequently "felt very confused" and lost consciousness.Paramedics were called and a blood glucose test of 30 mg/dl was obtained on the emergency services meter.The customer was treated with an unspecified iv medication for a diagnosis of hypoglycemia.A follow-up blood glucose of 40 mg/dl was obtained at the hospital on the hospital meter.No further information was provided.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: 10817211
• Report Number: 2954323-2020-10292
• Device Sequence Number: 13981695
• Product Code: NBW
• UDI-Device Identifier: 00699073708229
• UDI-Public: 00699073708229
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 11/10/2020

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 Expiration Date: 06/30/2022
• Device Model Number: 70805-70
• Device Catalogue Number: 70822
• Device Lot Number: 1127356
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2020
• Initial Report FDA Received Date: 11/10/2020
• 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: 81 YR