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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS ORTHO HCV 3.0; ASSAY, ELISA, HEPATITIS C VIRUS

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ORTHO CLINICAL DIAGNOSTICS ORTHO HCV 3.0; ASSAY, ELISA, HEPATITIS C VIRUS Back to Search Results
Catalog Number 930750
Device Problem Chemical Problem (2893)
Patient Problem No Information (3190)
Event Date 06/04/2018
Event Type  malfunction  
Manufacturer Narrative
Customer reported discrepant results on a cadaver sample when performing a comparison study between ortho hcv, lot txe665, and a competitor assay.The competitor's result was (b)(6).The ortho result was (b)(6).No confirmatory testing was performed in order to determine the accurate result.This was an isolated incident against this lot of product.A query of the world wide complaint database was performed for txe665 through 14jun2018.There were no other performance related complaint against this lot.
 
Event Description
Customer reported discrepant results on a cadaver sample, sample (b)(6), when performing a comparison study between ortho hcv, lot txe665, and a competitor assay.The competitor's result was (b)(6).The ortho result was (b)(6).No confirmatory testing was performed.Account pipettes and processes using the vip.Equipment maintenance is up to date.(b)(4).
 
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Brand Name
ORTHO HCV 3.0
Type of Device
ASSAY, ELISA, HEPATITIS C VIRUS
Manufacturer (Section D)
ORTHO CLINICAL DIAGNOSTICS
1001 route 202
raritan NJ 08869
Manufacturer (Section G)
ORTHO CLINICAL DIAGNOSTICS
1001 route 202
raritan NJ 08869
Manufacturer Contact
matthew p wictome
1001 route 202
raritan, NJ 08869
9082188223
MDR Report Key7635777
MDR Text Key112761164
Report Number2250051-2018-00062
Device Sequence Number1
Product Code MZO
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Medical Technologist
Type of Report Initial
Report Date 06/25/2018
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 Date11/01/2018
Device Catalogue Number930750
Device Lot NumberTXE665
Other Device ID Number10758750005277
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/04/2018
Initial Date FDA Received06/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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