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

Model Number	6L27-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/11/2020
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.Patient identifier multiple = (b)(6).There was no additional patient information provided by the customer.
Event or Problem Description
While running a comparative study between lots, the customer reported (b)(6) architect havab-g assay results for four patients on the current lot 12026be00, which was used for individual patient management.The customer provided: (b)(6) initial = (b)(6); (b)(6) initial = (b)(6); (b)(6) initial = (b)(6); (b)(6) initial = (b)(6).(ranges: (b)(6)).There was no impact to patient management reported.
Additional Manufacturer Narrative
The evaluation of the customer issue 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.Trending review determined no trend for this issue for the product.Device history record review did not identify any non-conformances or deviations associated with the customers issue.The overall performance of architect havab-g reagents in the field was reviewed and found to be acceptable.Based on all available information no product deficiency was identified.

• 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: 10093083
• Report Number: 3002809144-2020-00415
• Device Sequence Number: 17029389
• Product Code: LOL
• UDI-Device Identifier: 00380740011185
• UDI-Public: 00380740011185
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 07/29/2020

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: 6L27-25
• Device Catalogue Number: 06L27-25
• Device Lot Number: 12026BE00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2020
• Supplement Date Received by Manufacturer: 07/22/2020
• Initial Report FDA Received Date: 05/27/2020
• Supplement Report FDA Received Date: 07/29/2020
• 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 I2000SR; ARCHITECT I2000SR,; LN 03M74-02 , SN (B)(6); LN 03M74-02, SN (B)(6)