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U.S. Department of Health and Human Services

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

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ROCHE DIAGNOSTICS ELECSYS ANTI-HAV II; HEPATITIS A TEST Back to Search Results
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.
 
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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 Key11039756
MDR Text Key222823325
Report Number1823260-2020-03290
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
PMA/PMN Number
K190428
Number of Events Reported1
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 Date03/31/2021
Device Model NumberANTI-HAV II
Device Catalogue Number08086664190
Device Lot Number46606001
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 11/30/2020
Initial Date FDA Received12/18/2020
Supplement Dates Manufacturer Received11/30/2020
11/30/2020
Supplement Dates FDA Received12/29/2020
03/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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