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

• 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: 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6669466
• MDR Text Key: 78986228
• Report Number: 1319808-2017-00010
• 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: 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 Received: 06/27/2017
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 03/31/2018
• Device Catalogue Number: 6801997
• Device LOT Number: 1527-09-5708
• OTHER Device ID Number: 10758750001835
• 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 Received: 05/31/2017
• 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