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

Catalog Number 6801997

Device Problems False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or 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).

• Brand Name: VITROS CHEMISTRY PRODUCTS OP REAGENT
• Type of Device: IN 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 Key: 6169007
• MDR Text Key: 62677558
• Report Number: 1319808-2016-00042
• Device Sequence Number: 1
• Product Code: DJG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/10/2017
• Device Catalogue Number: 6801997
• Device Lot Number: 1527-09-5274
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1