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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 VITRO DIAGNOSTIC

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ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS OP REAGENT IN VITRO DIAGNOSTIC Back to Search Results
Catalog Number 6801997
Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2016
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 and oxycodone. Although there is no indication that the instrument was not performing as intended, an instrument issue cannot be completely ruled out as a contributing factor to the event. There is no information to suggest that the vitros op reagent malfunctioned.

 
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: 279 ng/ml (positive cutoff >or = 300 ng/ml) vs. >positive (2500 ng/ml oxycodone and 620 ng/ml oxymorphone). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros op-lo result was reported out of the laboratory. However, 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. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).

 
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Brand NameVITROS CHEMISTRY PRODUCTS OP REAGENT
Type of DeviceIN VITRO 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 Key6169007
MDR Text Key62677558
Report Number1319808-2016-00042
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 12/13/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/10/2017
Device Catalogue Number6801997
Device LOT Number1527-09-5274
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/10/2016
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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