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

Catalog Number	04P54-25
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/23/2019
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.All available patient information was included.Additional patient details are not available.Patient identifier: complete (b)(6).
Event or Problem Description
The customer reported a false reactive architect hbsag confirmatory test on one (b)(6)yr.Old female patient.(b)(6) confirmed reactive with hbsag neutralization assay on (b)(6) 2019 at 100%; roche hbv test and roche dna (quantitative assay) were not detected.Patient redrawn and tested on (b)(6) 2019, (b)(6) hbsag qualitative = 0.32 s/co (< 1.00 is nonreactive).Other results provided: hbcab = 0.08 s/co (nonreactive); ausab = 8.56 / 8.46 / 8.96 miu/ml.No impact to patient management was reported.
Additional Manufacturer Narrative
Ticket searches and performance testing could not be performed as the likely cause lot number is unknown.No customer returns were available for evaluation.The performance of the architect hbsag qualitative confirmatory assay was investigated by completing a review for non-conformances, potential non-conformances and deviations.This review did not identify any non-conformances, potential non-conformances or deviations.A review of the manufacturing documentation did not identify any issues associated with the customers observation.A review of labeling concluded that the issue is sufficiently addressed.No product deficiency was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE CONFIRMATORY
• Common Device Name: HBSAG CONFIRMATORY
• Manufacturer (Section D): ABBOTT IRELAND; diagnostics division; finisklin business park; sligo NA ; EI NA
• MDR Report Key: 9151396
• Report Number: 3008344661-2019-00116
• Device Sequence Number: 14233821
• Product Code: LOM
• UDI-Device Identifier: 00380740007799
• UDI-Public: 00380740007799
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/21/2019

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 Catalogue Number: 04P54-25
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 11/21/2019
• 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 ANALYZER LIST 03M74-02; ARCHITECT I2000SR ANALYZER LIST 03M74-02; SERIAL (B)(6); SERIAL (B)(6)
• Patient Age: 27 YR