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

Catalog Number 08P08-78

Device Problem False Positive Result (1227)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).All available patient information was included.No additional information was provided.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 8p08 that has a siliar product distributed in the us, list number 4p53 architect (b)(6).

Event Description

The customer reported false reactive alinity (b)(6) results were generated for a patient.The customer stated that on (b)(6) 2020 sid (b)(6) generated a result of 0.16 (reactive).[>/= to 0.05 iu/ml = reactive].This sample was not recentrifuged and retested after this initial reactive result.The patient was clinically diagnosed with uremia and was assigned to a dialysis machine designated for reactive (b)(6) patients based on the reactive result.A week later, the customer stated the same patient was tested again generated a result of 0 (nonreactive).The next day the patient was retested again with both the (b)(6) diluent reagent and (b)(6) reagent and generated the following results for sample barcode number (b)(6): (b)(6) diluent: initial result 0.12 (reactive); retest 0 (nonreactive) ; second retest 0 (nonreactive).(b)(6): initial 0 (nonreactive), retest 0 (nonreactive); second retest 0 (nonreactive).Confirmatory testing was not performed.There was no reported harm to the patient.

Manufacturer Narrative

This mdr is being submitted to correct section d2b: procode from ksj to lom.

Manufacturer Narrative

The complaint investigation for potential false reactive hbsag results included a search for similar complaints, trending data, labeling, and device history records.A review of the results stated in the ticket text was also performed.In-house testing of reagent lot 15029fn00 was completed.Return testing was not completed as returns were not available.A ticket search for lot 15029fn00 was performed and indicated that the alinity i hbsag assay was performing as expected; normal complaint activity was observed.A review of tracking and trending for the alinity i hbsag reagent did not identify any trends.In house testing of controls which mimic patient samples was completed using retained samples of lot 15029fn00; all specifications were met indicating that the lot is performing acceptably.Manufacturing documentation was reviewed and no issues were identified.Additionally, labeling was reviewed and adequately addresses the issue under review.Based on the investigation, no systemic issue or deficiency of the alinity i hbsag assay, lot number 15029fn00 was identified.

• Brand Name: ALINITY I HBSAG
• Type of Device: HBSAG
• Manufacturer (Section D): ABBOTT IRELAND DIAGNOSTICS DIVISION; finisklin business park; diagnostics division; sligo F91VY 44; EI F91VY44
• MDR Report Key: 10454950
• MDR Text Key: 244593621
• Report Number: 3008344661-2020-00065
• 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,Followup
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/20/2021
• Device Catalogue Number: 08P08-78
• Device Lot Number: 15029FN00
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ALINITY I PROCESSING MODULE,; ALNTY I PROCESSING MODU, 03R65-01, (B)(6); ALNTY I PROCESSING MODU, 03R65-01, (B)(6); LIST 03R65-01, SN (B)(6)
• Patient Outcome(s): Other