MAUDE Adverse Event Report: ABBOTT GMBH ABBOTT PRISM HBSAG ASSAY KIT; ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGM)

Catalog Number 03A47-48

Device Problem False Negative Result (1225)

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

Event Date 07/01/2022

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 3a47 has a similar product distributed in the us, list number 6d19.

Event Description

A literature article by e.Mah, h.Mokhtardin, and j.Raihand, ¿analysis of hbv nat yields in national blood centre, kuala lumpur (nbckl)¿, vox sanguinis 117.Suppl 1: 159.Blackwell publishing ltd.(2022), documented false nonreactive abbott prism hbsag results for 5 early seroconversion donor samples that were reactive with roche cobas.The aim of the article was to categorize hbv nat yields from nbckl (national blood centre, kuala lumpur) according to infection stages.To determine the demography, prevalence and hbv nat yield rate.The study looked at donor specimens that were screened nonreactive with abbott, but which were nat reactive between 2016 and 2021 to determine the infection stage.To categorize these further, the donor samples were retested in triplicate for nat.When the triplicate test produced reactive result, discriminatory test was performed with blood bag sample to determine the type of infection.When the hbv discriminatory test produced reactive result, the sample proceeded with hbv serology markers test (roche cobas system) to determine whether they were occult infection or window period infection.A total of 1,126,463 donations were screened between year 2016 to 2021.Out of the 1051 hbv infections detected during this period, 161 were hbv nat yields.Out of the 161 nbckl hbv nat yields, 90 were occult hepatitis b infection (obi), 49 were acute window period infection, 5 were early seroconversion, and 17 were unknown infection stage (hbv serology markers not tested).The hbsag of early seroconversion samples were nonreactive during screening donation, but reactive during serology markers testing with the roche cobas system.No impact to patient management was reported.

Manufacturer Narrative

The complaint investigation for false nonreactive abbott prism hbsag results for 5 early seroconversion donor samples included a review of data and information of the article ¿analysis of hbv nat yields in national blood centre, kuala lumpur (nbckl)¿, ticket trending review, labeling review, and device history record.Trending review did not identify any trends for the issue for the product.Device history record review did not identify any related non-conformances or deviations with list number 03a47 and the complaint issue.Labeling was reviewed and found to adequately address the issue under review.In this case, the absence of detailed donor history and specific hbv serologic marker test results, early seroconversion can be correlated with hbv dna and hbsag at barely detectable to undetectable levels, and that this reactivity profile can also be seen in chronic infection with occasional detectability of hbv genetic material replication.In these cases, the hbsag concentration may be low enough to be barely detectable or undetectable from an analytical standpoint, causing discrepant results between different serologic platforms and inconsistency on repeat testing with the same platform.Based on the investigation, no systemic issue or deficiency of the abbott prism hbsag assay, lot number unknown was identified.

• Brand Name: ABBOTT PRISM HBSAG ASSAY KIT
• Type of Device: ANTIBODY TO HEPATITIS B SURFACE ANTIGEN (MOUSE MONOCLONAL IGM)
• Manufacturer (Section D): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer (Section G): ABBOTT GMBH; max-planck-ring 2; wiesbaden 65205 ; GM 65205
• Manufacturer Contact: siobhan wright ; lisnamuck; post market surveillance; longford N39 E-932 ; EI N39 E932 ; 433331157
• MDR Report Key: 15090601
• MDR Text Key: 297054493
• Report Number: 3002809144-2022-00254
• Device Sequence Number: 1
• Product Code: QHM
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

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 Catalogue Number: 03A47-48
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ABBOTT PRISM SYST, 06A36-95, 082UNKNOWND12; ABBOTT PRISM SYST, 06A36-95, 082UNKNOWND12