MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT AUSAB REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Model Number	1L82-27
Medical Device Problem Codes	False Positive Result (1227); High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: (b)(6).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer observed false positive ausab results generated on an architect i1000sr analyzer for multiple patients, which repeated negative.The following sids were provided: (b)(6) initial result = 32.4, (b)(6) initial result = 19.56, (b)(6) initial result = 35.76.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review, field data review, and inhouse testing of retained reagent kit lot 31157fn00.Return testing was not completed as returns were not available.Data and information provided by the customer were reviewed and support the complaint issue without indication for any additional issue.Ticket and trending review did not identify any trends for the complaint issue.Device history record review did not identify any non-conformances or deviations with the likely cause lot number.Clinical specificity testing was performed using an in-house retain kit of lot 31157fn00.All specifications were met indicating the lot is performing acceptably.The overall performance of the architect ausab reagents in the field was reviewed using data gathered from customers worldwide.The median patient result for lot 31157fn00 for nonreactive results falls within 1sd of the overall mean result, indicating that the reagent lot is performing acceptably on market.Labeling was reviewed and found to adequately address the issue under review.Based on the investigation, no systemic issue or deficiency with the architect ausab reagent lot 31157fn00 was identified.
Additional Manufacturer Narrative
Corrected information in section d9 device available for eval and h6 medical device problem code.
Additional Manufacturer Narrative
Corrected information in h4 from previously submitted supplemental report.

• Brand Name: ARCHITECT AUSAB REAGENT KIT
• Common Device Name: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer (Section G): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 13632172
• Report Number: 3008344661-2022-00015
• Device Sequence Number: 19373928
• Product Code: LOM
• UDI-Device Identifier: 00380740115364
• UDI-Public: 00380740115364
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/22/2022
• Device Model Number: 1L82-27
• Device Catalogue Number: 01L82-27
• Device Lot Number: 31157FN00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2022
• Supplement Date Received by Manufacturer: 04/05/2022; 08/04/2022; 12/07/2022
• Initial Report FDA Received Date: 03/01/2022
• Supplement Report FDA Received Date: 04/07/2022; 08/05/2022; 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARC I1000SR MOD, 01L86-01, I1SR60972; ARC I1000SR MOD, 01L86-01, I1SR60972; ARC I1000SR MOD, 01L86-01, I1SR60972; ARC I1000SR MOD, 01L86-01, I1SR60972
• Patient Sex: Unknown