MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST

Model Number ANTI-HAV II

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for three patient samples tested with the elecsys anti-hav gen.2 assay on a cobas pro e 801 module.Samples 2 and 3 also had discrepant results when tested on a cobas 8000 e 801 module at a second site.No incorrect results were reported outside of the laboratory.The reporter states that samples that are (b)(6) with the elecsys anti-hav gen.2 assay will always have cutoff index values around (b)(6) values will always be around (b)(6) and never more than (b)(6).These values are very close to the cutoff of the assay (b)(6).The first sample resulted with an (b)(6) when tested on the customer's cobas pro e 801 analyzer on (b)(6) 2020.This sample was repeated on the customer's e 801 analyzer on (b)(6) 2020, resulting with (b)(6).The sample was sent to another laboratory for testing on an abbott architect analyzer, resulting with (b)(6).The second sample resulted with an (b)(6) when tested on the customer's e 801 analyzer on 27-nov-2020.The sample was repeated on the customer's e 801 analyzer on (b)(6) 2020, resulting with (b)(6).The sample was sent to another laboratory for testing on a cobas 8000 e 801 analyzer, resulting with (b)(6).When sent to another site for testing on an abbott architect analyzer, this sample resulted with a (b)(6).The third sample resulted with an (b)(6) when tested on the customer's e 801 analyzer on (b)(6) 2020.The sample was repeated on the customer's e 801 analyzer on (b)(6) 2020, resulting with a (b)(6).The sample was sent to another laboratory for testing on a cobas 8000 e 801 analyzer, resulting with a (b)(6).When sent to another site for testing on an abbott architect analyzer, this sample resulted with a (b)(6).The serial number of the customer's e 801 analyzer is (b)(4).

Manufacturer Narrative

The reporter stated they received discrepant elecsys anti-hav gen.2 results for two additional patient samples (samples 4 and 5).It is unknown if any incorrect results were reported outside of the laboratory for samples 4 and 5.The abbott architect data provided in the initial medwatch is for the abbott anti-hav igg assay.For samples 2-5, the reporter has provided additional measurements.Refer to the attachment for a summary of all values that were provided, including those initially reported.Samples 2-5 were repeated again using the following methods: the elecsys anti-hav gen.2 assay on the customer's e 801, the elecsys anti-hav (gen.1 quantitative assay) on the e 801 analyzer at the second site, an unknown anti-hav igm assay at the customer site, and an abbott anti-hav igm assay.

Manufacturer Narrative

The patient samples were provided for investigation and the results obtained by the customer could be duplicated.The samples contained no evidence of interfering antibodies.The samples are considered true anti-hav positive.

• Brand Name: ELECSYS ANTI-HAV II
• Type of Device: HEPATITIS A TEST
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11039756
• MDR Text Key: 222823325
• Report Number: 1823260-2020-03290
• Device Sequence Number: 1
• Product Code: LOL
• Combination Product (y/n): N
• PMA/PMN Number: K190428
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2021

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: 03/31/2021
• Device Model Number: ANTI-HAV II
• Device Catalogue Number: 08086664190
• Device Lot Number: 46606001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 11/30/2020; 11/30/2020
• Supplement Dates FDA Received: 12/29/2020; 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1