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

Model Number	70805-70
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	02/01/2020
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 there was no indication that the product did not meet specification.Dhrs (device history review) for the fs lite meter were reviewed and the dhrs showed the fs lite passed all tests prior to release.Dhrs (device history review) for the freestyle strips were reviewed and the dhrs showed the freestyle strips passed all tests prior to release.Retain testing was performed 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.The exact date that the incident occurred is unknown.The date entered is based on the customer report of "one month ago".All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer reported having unspecified readings issue with the use of adc blood glucose meter.On an unspecified date, customer felt "very sick, lightheaded and high blood pressure" and was seen at the hospital where an unspecified reading was obtained on the hcp meter.Customer was diagnosed with hyperglycemia and received unspecified treatment.Customer additionally reported that she self-treated with unknown dose of insulin but it is unknown if it was before going to the hospital.No further information was provided.There was no report of death or permanent impairment 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: 9808544
• Report Number: 2954323-2020-01911
• Device Sequence Number: 16866603
• Product Code: NBW
• UDI-Device Identifier: 00699073121011
• UDI-Public: 00699073121011
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/09/2020

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: 04/30/2021
• Device Model Number: 70805-70
• Device Catalogue Number: 12101
• Device Lot Number: 1085142
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 03/09/2020
• 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: 62 YR
• Patient Weight: 73