MAUDE Adverse Event Report: ABBOTT IRELAND DIAGNOSTICS DIVISION ALINITY S HBSAG

Catalog Number 06P02-55

Device Problem False Positive Result (1227)

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

Event Date 05/02/2020

Event Type  malfunction  

Manufacturer Narrative

An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.Patient identifier complete entry = (b)(6).All available patient information was included.Additional patient details are not available.This report is being filed on an international product, list number 06p02-55 that has a similar product distributed in the us, list number 6p02-60.

Event Description

The customer observed a false nonreactive alinity s (b)(6) reagent kit result for one female donor.The following data was provided (<1.00 s/co is nonreactive, >/= 1.00 is reactive): sample id (b)(6) initial result, on (b)(6) 2020, was 0.49 s/co.The sample was tested using grifols end point pcr, which was 12.33 s/co (>/=1.00 s/co is reactive), and roche taqman (b)(6) dna which was <6 iu/ml (<6 iu/ml is reactive).The sample was sent to a reference laboratory with the following results tested on (b)(6) 2020: diasorin murex (b)(6) was positive, architect (b)(6) was <10 iu/ml (<10 iu/ml is nonreactive), biomerieux vidas (b)(6) total ii (b)(6) was positive, architect (b)(6) igm and roche cobas (b)(6) igm were negative.There was no impact to patient management reported.

Manufacturer Narrative

Review of complaint activity associated with the complaint lot identified normal complaint activity.Review of tracking and trending reports for the alinity s hbsag assay, lot number 10185fn00, did not identify any related trends.The returned sample was tested with a retained kit of alinity s hbsag reagent, lot number 10185fn00.The returned specimen was non-reactive with a result of 0.76 s/co.Therefore, the acceptance criteria were not met, and the customer observation was confirmed.Sensitivity testing was performed using an in-house retained kit of lot 10185fn00 stored at the recommended storage condition.The sensitivity panel met specifications and the results were in the typical range and no false non-reactive results were obtained.In addition, the clinical sensitivity was evaluated by testing a commercially available seroconversion panel (zeptometrix hepatitis b seroconversion panel hbv 11003).Reagent lot 10185fn00 detected the same bleeds as reactive for the seroconversion panel as historical lots.Device history record review did not identify any non-conformances or deviations with the likely cause lot and complaint issue.Manufacturing documentation for the likely cause lot was reviewed and did not identify any issues.Labeling was reviewed and sufficiently addresses the customer's issue.No systemic issue or deficiency of the alinity s hbsag assay was identified.Based on the information provided and abbott diagnostics' complaint investigation, no product deficiency was identified.

Event Description

On (b)(6) 2020, the customer provided the following additional patient data: another sample was collected from this patient, sample id (b)(6), initial result on 05jun2020, was 0.59 s/co.The sample was also sent to a reference laboratory and the following results were provided: diasorin murex hbsag version 3 results were 0.744, 0.833, 0.752 s/co (negative) abbott architect anti-hbs assay result was <10 mu/ml (negative) biomerieux vidas anti-hbc total ii result was positive abbott architect anti-hbc igm and roche cobas anti-hbc igm were negative.There was no impact to patient management reported.

Manufacturer Narrative

Additional patient data provided by the customer on 16jul2020 was added to section b5.

• Brand Name: ALINITY S HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo NA ; EI NA
• MDR Report Key: 10155727
• MDR Text Key: 228607387
• Report Number: 3008344661-2020-00047
• Device Sequence Number: 1
• Product Code: QHM
• 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,Followup
• Report Date: 08/21/2020

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: 10/29/2020
• Device Catalogue Number: 06P02-55
• Device Lot Number: 10185FN00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 06/15/2020
• Supplement Dates Manufacturer Received: 07/16/2020; 08/17/2020
• Supplement Dates FDA Received: 08/04/2020; 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY S SYSTEM, LIST# 06P16-01,; ALINITY S SYSTEM, LIST# 06P16-01,; ALINITY S SYSTEM, LIST# 06P16-01,; SERIAL# (B)(6) ; SERIAL# (B)(6) ; SERIAL# (B)(6)