MAUDE Adverse Event Report: ABBOTT LABORATORIES PRISM HBCORE; ANTI-HBC

Catalog Number 01A77-48

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

Patient Problem Hepatitis (1897)

Event Date 04/01/2018

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 1a77 that has a similar product distributed in the us, list number 6e66.Note, manufacturer report number 1415939-2018-00092 documents the issue for the prism hbsag method.O'flaherty, n., et al.Transfusion transmitted hepatitis b virus (hbv) infection from an individual donation nucleic acid (id nat) non reactive donor.Vox sanguinis (2018).An evaluation is in process.

Event Description

The source literature identified one case of a blood transfusion that transmitted (b)(6) to a recipient.The literature article documents a (b)(6) blood unit that had been tested using prism hbcore and prism hbsag reagents.The donor was subsequently diagnosed with an acute (b)(6) infection (b)(6) and (b)(6) dna viral load was detected in the recipient.The following information was provided, however no specific prism results values were provided.Donated unit (b)(6) and (b)(6) results were (b)(6) while using the prism methods.The specimen was also (b)(6) using ultrio elite (multiplex hiv-1/2, hcv, hbv) method.The individual was a repeat blood donor.The blood transfusion customer was notified of the donor diagnosis of (b)(6) infection (b)(6) 108 days after the last donation, when the donor presented with a short history of jaundice and fatigue due to (b)(6) infection.An archived specimen of the last donation was retested.Archived specimen test showed the donor specimen was (b)(6) using prism methods (hbsag and anti-hbc) and ultrio elite (multiplex hiv-1/2, hcv, hbv) method.Archived specimen testing showed the donor specimen was (b)(6) using dhbv dna ultrio elite assay.Insufficient volume remained to complete hbv dna viral load testing.Results for the donor in the symptomatic phase (108 days post donation) were provided, and showed (b)(6) using architect methods (hbsag, anti-hbc total, anti-hbc igm, and anti-hbe).(b)(4) dna viral load (abbott real-time pcr) method showed viral load was detected, (b)(6).An immunocompromised recipient of the implicated unit red blood cell component was tested 110 days post transfusion and revealed an (b)(6) dna viral load was detected, (b)(6).The recipient had been diagnosed with acute myeloid leukemia before being transfused with the affected unit.The asymptomatic recipient was treated with entecavir (0.5 mg once daily) and (b)(6) dna viral load was detected 121 days post transfusion, less than (b)(6).Genotype c2 sequences identical across two regions of the (b)(6) genome were found in samples from the donor and recipient.Recipient results using architect anti-hbc (total) and architect anti-hbc igm were (b)(6) pretransfusion and post transfusion.Recipient results using architect hbsag were (b)(6) pretransfusion and 110 days post transfusion, however were (b)(6) using architect hbsag and murex hbsag neutralization 121 days post transfusion.

Manufacturer Narrative

Evaluation of the customer issue included a complaint text review, a search for similar complaints, device history review, and labeling review.No adverse trend was identified for the customer issue.Device history review did not identify any issues that may have caused the customer issue.The product was not returned.Additional scientific literature was reviewed with medical affairs related to the complaint issue.During early hbv infection phase, a donor specimen hbv rna per nucleic acid testing (nat) will be detected earlier than hepatitis b surface antigen and antibodies.For the complaint donor specimen, no nat was detected in that early stage of infection; the prism hbsag and prism hbcore assays, as well as the architect hepatitis b assays could not detect any analyte.Labeling was reviewed and found to be adequate.The product package insert limitations of the procedure section includes that although the association of infectivity and the presence of anti-hbc is strong, it is recognized that presently available methods for anti-hbc detection are not sensitive enough to detect all potentially infectious units of blood, plasma or possible cases of hbv infection.A nonreactive test result does not exclude infection.Based on all available information and abbott diagnostics evaluation, no systemic issue was identified and no product deficiency was found.Note, prism methods were used for testing of the donated unit and the architect methods were used for diagnostic purposes.The following manufacturer report numbers document the issue for the other methods.Prism hbsag method manufacturer report number 1415939-2018-00092.Architect anti-hbc ii method manufacturer report number 3002809144-2018-00057.Architect hbsag method manufacturer report number 3008344661-2018-00046.Architect anti-hbc igm method manufacturer report number 3002809144-2018-00058.

• Brand Name: PRISM HBCORE
• Type of Device: ANTI-HBC
• Manufacturer (Section D): ABBOTT LABORATORIES; 100 abbott park road; abbott park IL 60064 3500
• MDR Report Key: 7567510
• MDR Text Key: 110575782
• Report Number: 1415939-2018-00091
• 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,l
• Type of Report: Initial,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 01A77-48
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 06/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LIST NUMBER 06A36-04; LIST NUMBER 06A36-04; PRISM ANALYZER; PRISM ANALYZER; SERIAL NUMBER (B)(4); SERIAL NUMBER (B)(4)
• Patient Outcome(s): Disability