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

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).

• Brand Name: VITROS CHEMISTRY PRODUCTS OP REAGENT
• Type of Device: IN-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 Key: 5084841
• MDR Text Key: 26488329
• Report Number: 1319808-2015-00017
• 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

• 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 Received: 09/17/2015
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 08/01/2016
• Device Catalogue Number: 6801997
• Device LOT Number: 1527-09-4374
• Was Device Available For Evaluation?: Yes

Is The Reporter A Health Professional?

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse