MAUDE Adverse Event Report: ABBOTT GMBH ARCHITECT HAVAB-G; IGG ANTI-HAV

Model Number	N/A
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.
Event or Problem Description
The customer reported false reactive architect (b)(6) results on multiple patients.The following data was provided (reference range: < 1.0 s/co = nonreactive, >= 1.00 s/co = reactive): patient #1 = 1.05 s/co (old), 0.31 s/co (new); patient #2 = 1.09 s/co (old), 0.62 s/co (new); patient #3 = 1.52 s/co (old), 0.62 s/co (new); patient #4 = 1.19 s/co (old), 0.39 s/co (new); patient #5 = 1.05 s/co (old), 0.30 s/co (new); patient #6 = 1.61 s/co (old), 0.48 s/co (new); patient #7 = 1.56 s/co (old), 0.53 s/co (new).The initial (b)(6) results with the old lot are reactive, repeat results using the new lot are nonreactive.There was no impact to patient management reported.
Additional Manufacturer Narrative
The complaint investigation for false reactive results for seven samples tested with the architect havab-g assay included a review of data and information provided by the customer, search for similar complaints, ticket trending review, labeling review, device history record review and field data review.Return testing was not completed as returns were not available.Trending review determined no related trends for the issue for the product.Device history record review did not identify any non-conformances or deviations associated with the likely cause lot(s) and complaint issue.The overall performance of architect havab-g reagents in the field was reviewed using worldwide data and determined that the performance of the complaint lot(s) is acceptable.Product labeling review determined that the issue was adequately addressed.Based on the investigation, we have determined that there is no systemic issue and/or product deficiency for the architect havab-g reagent lot(s) identified in this complaint.Section d11: concomitant medical products and therapy dates: original: architect i2000sr analyzer ; changed to: architect i1000sr analyzer.

• Brand Name: ARCHITECT HAVAB-G
• Common Device Name: IGG ANTI-HAV
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• MDR Report Key: 10335032
• Report Number: 3002809144-2020-00749
• Device Sequence Number: 3623859
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 12/02/2020
• Device Model Number: N/A
• Device Catalogue Number: 06L27-25
• Device Lot Number: 12026BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2020
• Supplement Date Received by Manufacturer: 09/09/2020
• Initial Report FDA Received Date: 07/28/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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: ARCHITECT I 1000SR ANALYZER,; ARCHITECT I2000SR ANALYZER,; LIST 01L86-01, SERIAL (B)(6); LIST 01L86-01, SERIAL (B)(6)