MAUDE Adverse Event Report: ABBOTT IRELAND ARCHITECT ANTI-HBS REAGENT KIT; TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)

Catalog Number 07C18-78

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/26/2021

Event Type  malfunction  

Manufacturer Narrative

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 07c18 that has a similar product distributed in the us, list number 01l82.

Event Description

The customer observed a (b)(6) architect (b)(6) result for one patient diagnosed with chronic granulocytic leukemia.Per the record, the patient had received a blood transfusion on (b)(6) 2021.The architect (b)(6) result on (b)(6) 2021 was (b)(6); the previous result was (b)(6).No adverse impact to patient management was reported.

Event Description

The customer observed a false reactive architect anti-hbs result for one patient diagnosed with chronic granulocytic leukemia.Per the record, the patient had received a blood transfusion on (b)(6) 2021.The architect anti-hbs result on (b)(6) 2021 was 17 miu/ml (reference range =10 miu/ml); the previous result was negative.No adverse impact to patient management was reported.Update: the patient is male.The sample was retested on another i2000sr instrument at the customer¿s site, and the result was 15 miu/ml.

Manufacturer Narrative

Additional information found in the following fields: a3.Gender.B5.Describe event.D4.Lot no.An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

The complaint investigation included a search for similar complaints, and the review of the complaint text, trending data, labelling, and device history records.Return testing was not completed as returns were not available.A review of tracking and trending did not identify any trends for the complaint issue.Device history record review did not identify any issues associated with lot 24116fn01 and the complaint issue.Historical performance was evaluated using worldwide field data and indicated that the patient median result for the lot is comparable with all other lots in the field and within established baselines, confirming no systemic issue for the product lot.Labelling was reviewed which adequately addresses the issue under review.If the anti-hbs results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.For diagnostic purposes, results should be used in conjunction with patient history and other hepatitis markers for diagnosis of acute, chronic, or recovered infection.Based on the investigation, no systemic issue or deficiency of the architect anti-hbs assay, lot number 24116fn01 was identified.

• Brand Name: ARCHITECT ANTI-HBS REAGENT KIT
• Type of Device: TEST, HEPATITIS B (B CORE, BE ANTIGEN, BE ANTIBODY, B CORE IGM)
• Manufacturer (Section D): ABBOTT IRELAND; finisklin business park; sligo F91VY 44; EI F91VY44
• MDR Report Key: 12122359
• MDR Text Key: 260079469
• Report Number: 3008344661-2021-00136
• Device Sequence Number: 1
• Product Code: LOM
• Combination Product (y/n): N
• PMA/PMN Number: P050051
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2022
• Device Catalogue Number: 07C18-78
• Device Lot Number: 24116FN01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, (B)(6).; ARC I2000SR INST, 03M74-02, ISR61756