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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITROS DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS OP REAGENT IN-VITROS DIAGNOSTIC Back to Search Results
Catalog Number 6801997
Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/13/2015
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that a discordant, negative vitros op-lo result was obtained from a single patient sample run on the vitros 5600 integrated system. The intended use section of the vitros op ifu states that the vitros chemistry product op assay is intended for use by professional laboratory personnel. It provides only a preliminary test result. A more specific alternative chemical method must be used to confirm a result obtained with the vitros op assay. Gas chromatography/mass spectrometry (gcms) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug-of-abuse test result. The likely cause is a known limitation of the vitros op reagent related to low cross reactivity with oxymorphone. There is no evidence that an instrument issue contributed to the event. The customer¿s calibration of the vitros op-lo reagent in use at the time or an unidentified reagent issue could not be ruled out as contributing factors.

 
Event Description

The customer obtained a discordant, negative vitros op-lo result from a single patient sample run on the vitros 5600 integrated system, when compared to a positive opiate result obtained using the gc/ms method. Vitros patient result: 277 ng/ml (positive cutoff >or = 300 ng/ml) vs. >12000 ng/ml (positive). Biased results of the magnitude and direction observed may lead to inappropriate physician action. It is not known if the discordant vitros op-lo result was reported out of the laboratory. There was no report of treatment started, stopped, or altered based on the false negative vitros op-lo result and there was no report of patient harm as a result of this event. (b)(4).

 
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Brand NameVITROS CHEMISTRY PRODUCTS OP REAGENT
Type of DeviceIN-VITROS DIAGNOSTIC
Manufacturer (Section D)
ORTHO-CLINICAL DIAGNOSTICS
100 indigo creek drive
rochester NY 14626
Manufacturer (Section G)
ORTHO-CLINICAL DIAGNOSTICS
1000 lee road
rochester NY 14606
Manufacturer Contact
james a stevens
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key5084841
MDR Text Key26488329
Report Number1319808-2015-00017
Device Sequence Number1
Product Code DJG
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
Type of Report Initial
Report Date 09/17/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/01/2016
Device Catalogue Number6801997
Device LOT Number1527-09-4374
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2015
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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