MAUDE Adverse Event Report: ABBOTT DIABETES CARE INC. PRECISION XTRA; BLOOD GLUCOSE MONITORING SYSTEM

Model Number	98814-65
Medical Device Problem Code	Low Readings (2460)
Health Effect - Clinical Codes	Fatigue (1849); Hyperglycemia (1905)
Date of Event	07/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product has been requested back for an investigation.A follow-up report will be submitted once additional information is obtained.All pertinent information available to abbott diabetes care has been submitted.
Event or Problem Description
Customer's daughter reported that on (b)(6) 2018 at 12:00 p.M., the customer received a reading of 108 mg/dl on his adc blood glucose meter which was lower than he felt.It was further reported the customer experienced feeling "sleepy and tired" and was seen at a hospital where a reading of 302 mg/dl was obtained on the hospital meter at 1:00 p.M.Customer was diagnosed with hyperglycemia and treated with "2-3 bags" of intravenous fluids "to lower glucose".There was no report of death or permanent impairment associated with this event.
Event or Problem Description
Customer's daughter reported that on (b)(6) 2018 at 12:00 p.M., the customer received a reading of 108 mg/dl on his adc blood glucose meter which was lower than he felt.It was further reported the customer experienced feeling "sleepy and tired" and was seen at a hospital where a reading of 302 mg/dl was obtained on the hospital meter at 1:00 p.M.Customer was diagnosed with hyperglycemia and treated with "2-3 bags" of intravenous fluids "to lower glucose".There was no report of death or permanent impairment associated with this event.
Additional Manufacturer Narrative
Additional information:(serial number) was modified to unk as serial number reported was deemed invalid based on the extended investigation.No product was returned.Extended investigation was performed for the reported complaint and determined that there was no indication that the product did not meet specification.Dhrs (device history review) for precision xceed meters determined no discrepancies, deviations or nonconformance's.Dhr (device history review) for the precision xtra strips were reviewed and the dhr showed the precision xtra strips passed all tests before release.Retain testing was performed and all units performed within specification.A tripped trend review was completed for the reported complaint and determined that there were no confirmed complaints within the trend data in this review.If the product is returned, the case will be re-opened and a physical investigation will be performed.This also serves as a correction report.Pma/510(k) # was incorrectly documented in the initial mdr.Pma/510(k has been updated.

• Brand Name: PRECISION XTRA
• 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: 7762864
• Report Number: 2954323-2018-05925
• Device Sequence Number: 11201899
• Product Code: NBW
• UDI-Device Identifier: 00093815998389
• UDI-Public: 00093815998389
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K040814
• 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,Followup
• Report Date (Section B): 05/22/2019

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: 12/31/2018
• Device Model Number: 98814-65
• Device Lot Number: 4500169237
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 05/22/2019
• 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: 57 YR
• Patient Weight: 82