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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)

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ROCHE DIAGNOSTICS ELECSYS ANTI-HAV IGM HEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY) Back to Search Results
Catalog Number 07026773190
Device Problem Patient Data Problem (3197)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Manufacturer Narrative
The investigation determined the application file created for the (b)(6) igm instrument settings was incorrect. The application file was assigned cutoff ranges for the(b)(6) igm reagent used outside of the united states. In the settings used in the rest of the world, there is no borderline cutoff range for the (b)(6) igm assay. Values with a coi of < 1. 0 are "non reactive" and values with a coi >
=
1. 0 are "reactive".
 
Event Description
The initial reporter stated they received questionable results for an unspecified number of patient samples tested with elecsys (b)(6) igm on a cobas 8000 e 801 module. The result interpretation assigned to these samples from the analyzer software did not appear to be correct as the interpretation did not agree with the cutoff values documented in product labeling. The customer provided examples of (b)(6)igm results from two pooled patient samples and the result interpretation for these samples were discrepant. No incorrect results were reported outside of the laboratory as the customer was using pooled samples to validate the system software. The first sample resulted with an (b)(6) igm value of 0. 926 coi. The analyzer software assigned a result interpretation of "non reactive". Based on product labeling, the interpretation for this value should be "borderline" as the cutoff values for "borderline" are >
=
0. 90 coi and < 1. 10 coi. The second sample resulted with an (b)(6) igm value of 1. 02 coi. The analyzer software assigned a result interpretation of "reactive". Based on product labeling, the interpretation for this value should be "borderline" as the cutoff values for "borderline" are >
=
0. 90 coi and < 1. 10 coi. The e 801 analyzer serial number is (b)(4).
 
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Brand NameELECSYS ANTI-HAV IGM
Type of DeviceHEPATITIS A TEST (ANTIBODY AND IGM ANTIBODY)
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 Key9238887
MDR Text Key219582755
Report Number1823260-2019-03859
Device Sequence Number1
Product Code LOL
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093955
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/25/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number07026773190
Device Lot Number435246
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 Received10/02/2019
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
Removal/Correction NumberRES81823

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