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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 Resultor 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).
 
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Brand NameELECSYS ANTI-HAV II
Type of DeviceHEPATITIS A TEST
Manufacturer (Section D)
ROCHE DIAGNOSTICS
9115 hague road
indianapolis IN 46250 0457
Manufacturer (Section G)
ROCHE DIAGNOSTICS GMBH
sandhoferstrasse 116
na
mannheim (baden-wurttemberg) 68305
GM 68305
Manufacturer Contact
michael leslie
9115 hague road
na
indianapolis, IN 46250
3175214343
MDR Report Key11039756
MDR Text Key222823325
Report Number1823260-2020-03290
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeTH
PMA/PMN Number
K190428
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Model NumberANTI-HAV II
Device Catalogue Number08086664190
Device Lot Number46606001
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/30/2020
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
Type of Device Usage Invalid Data

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