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

Catalog Number 02G22-30

Device Problem False Positive Result (1227)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information: no further patient information was provided by the customer.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.This report is being filed on an international product, list number 2g22 that has a similar product distributed in the us, list number 4p53.The reportability determination include both likely causes: architect hbsag qualitative ii, list 02g22-25, lot 02357fn00 and architect hbsag qualitative ii confirmatory, list 02g23-25, lot 01542fn00.Each list number will have a separate submission.

Event Description

The customer observed a false repeat reactive architect hbsag qualitative ii and architect hbsag qualitative ii confirmatory results for 2 samples.The following data was provided: sample 1 (b)(6) 2019: hbsag = 2.71 s/co (reactive), repeats = 3.04 s/co and 3.01 s/co, hbsag confirmatory: c1 = 0.18 s/co, c2 = 2.59 s/co, neutralization = 103.16 %, repeat = 103.16%, the following assays were negative: anti-hbc, anti-hbe, anti-hbs = 0.62 iu/ml, hbv dna = negative.Sample 2 (b)(6) 2020: hbsag = 1.07 s/co (reactive), repeats = 1.06 s/co and 1.07 s/co, hbsag confirmatory: c1 = 0.23 s/co, c2 =1.00 s/co, neutralization = 95.32%, repeat = 85.32% the following assays were negative: anti-hbc, anti-hbe, anti-hbs = 0 iu/ml, hbv dna = negative.No impact to patient management was reported.Per the discrepant test results for hbsag section of dfp01.014 edition 020, when the observed result was repeat reactive and confirmed by neutralization per package insert requirements and negative by other testing the event is reportable.

Manufacturer Narrative

Correction of section d.Suspect medical device: 2.Product code: from ksj to lom on 20apr2020.Update of section d.Suspect medical device: 3.Lot#: updated to 07210fn00 on 03apr2020.The product evaluation include both likely causes: architect hbsag qualitative ii, list 02g22-30, lot 07210fn00 and architect hbsag qualitative ii confirmatory, list 02g23-25, lots 95027fn00 and 09075fn00.Each list and lot number will have a separate submission, see manufacturer report numbers 3008344661-2020-00023 and 3008344661-2020-00032.A review of tickets was performed for reagent lot numbers 07210fn00, 95027fn00, and 09075fn00.The ticket search determined that there is normal complaint activity for the likely cause lots.A review of tracking and trending did not identify any trends for the complaint issue.Return testing was not completed as returns were not available.Field data was used to evaluate the performance of the architect hbsag qualitative ii assay.The number of standard deviations to the cutoff for the negative population tested showed lot 07210fn00 is within the established limits.Review of the median patient results by reagent lot report showed no atypical performance for lot 07210fn00.Specificity testing of negative panels, which mimics patient samples, was performed using in-house retained kits of architect hbsag qualitative ii confirmatory assay with lots 95027fn00 and 09075fn00.All specifications were met indicating that the lots are performing acceptably.A review of the manufacturing documentation did not identify any issues associated with the complaint issue.A review of labeling concluded that the issue is sufficiently addressed.Based on the investigation no systemic issue or deficiency of the architect hbsag qualitative ii assay, lot 07210fn00 or of the architect hbsag qualitative ii confirmatory assay, lots 95027fn00 and 09075fn00 was identified.

• Brand Name: ARCHITECT HBSAG QUALITATIVE II
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 9806090
• MDR Text Key: 263461361
• Report Number: 3008344661-2020-00023
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2020
• Device Catalogue Number: 02G22-30
• Device Lot Number: 07210FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/09/2020
• Supplement Dates Manufacturer Received: 04/03/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCHITECT I2000SR PROCESSING MODULE; ARCHITECT I2000SR, LN 03M74-02; HBSAG CONFIRMATORY, LIST 02G23-25, LOT 95027FN00; LIST 03M74-02, SERIAL (B)(6) , ARCHITECT; LN 02G23-25, LOTS 95027FN00, 09075FN00; SERIAL (B)(6) , HBSAG CONFIRMATORY