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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 Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/31/2017
Event Type  Malfunction  
Manufacturer Narrative

The investigation determined that unexpected discordant vitros op negative results were obtained from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients when tested on a vitros 5600 integrated chemistry system. The vitros chemistry products 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 this assay. Gas chromatography/mass spectrometry (gc/ms) 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 synthetic opioids. The customer did not send the samples for additional testing to confirm. There is no evidence to suggest that the vitros op reagent lot 1527-09-5708 malfunctioned. 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

A customer obtained unexpected discordant vitros op negative results using a <300 ng/ml cutoff from samples from three separate patients which were reported as op negative when the physician expected a positive op result from all three patients due to their condition (heroin overdose), on a vitros 5600 integrated chemistry system. Patient 1 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 2 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Patient 3 vitros result < 100 ng/ml (negative) versus an expected positive result (>300 ng/ml). Biased results of the magnitude and direction observed may lead to inappropriate physician action. The discordant vitros op-lo results were reported out of the laboratory. However, there was no report of treatment started, stopped, or altered based on the false negative vitros op-lo results and there was no report of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics (ortho) inc. Complaint numbers (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
100 indigo creek drive
rochester, NY 14626
5854533000
MDR Report Key6669466
MDR Text Key78986228
Report Number1319808-2017-00010
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 MEDICAL TECHNOLOGIST
Type of Report Initial
Report Date 06/27/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/27/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date03/31/2018
Device Catalogue Number6801997
Device LOT Number1527-09-5708
OTHER Device ID Number10758750001835
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 Received05/31/2017
Was Device Evaluated By Manufacturer? Yes
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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