MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ARCHITECT HBSAG QUALITATIVE CONFIRMATORY; HBSAG CONFIRMATORY

Model Number	4P54-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/15/2020
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.Section a patient information: no specific patient information was provided.
Event or Problem Description
The customer obtained a false positive architect hbsag qualitative confirmatory result.Sample id (b)(6) generated repeat reactive hbsag results of 16.82 s/co with a similar retest and confirmed reactive with the hbsag confirmatory assay.A new specimen (s2676581) was collected two weeks later and generated repeat reactive hbsag results 16.27 s/co with a similar retest result and not confirmed when tested with the hbsag confirmatory assay.The sample was also sent to an alternate labe and generated a non-reactive result.A third sample (t4178124) generated non-reactive results on confirmation.No impact to patient management was reported.
Additional Manufacturer Narrative
Review of trending reports did not identify any related trends for the architect hbsag qualitative confirmatory assay.Normal complaint activity was identified for reagent lot 08014fn00.Testing of panels which mimic patient samples was performed using a retained kit of lot 08014fn00.All specifications were met indicating that the lot is performing acceptably.Manufacturing documentation for the reagent lot was reviewed and did not identify any issues associated with the issue.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the architect hbsag qualitative confirmatory assay was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9722645
• Report Number: 3008344661-2020-00016
• Device Sequence Number: 18914551
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• PMA/510(K) Number: P110029
• 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): 03/25/2020

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: 04/26/2020
• Device Model Number: 4P54-25
• Device Catalogue Number: 04P54-25
• Device Lot Number: 08014FN00
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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, LIST 03M74-02,; ARCHITECT I2000SR, LIST 03M74-02,; SERIAL (B)(6) ; SERIAL (B)(6)