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

Catalog Number 6801989

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a discordant, negative vitros benz result was obtained from a single patient sample using the vitros 5600 integrated system, when compared to a positive result obtained using two different non-vitros methods.The compound detected by the non-vitros methods was temazepam glucuronide.The intended use section of the vitros benz ifu states that the vitros chemistry product benz 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 benz 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 most likely cause is a known limitation of the vitros benz reagent related to low cross reactivity with temazepam glucuronide.There is no evidence that a reagent related issue contributed to the event.

Event Description

A customer obtained a discordant, negative vitros benz result for single patient sample run on the vitros 5600 integrated system when compared to a positive result obtained using two different non-vitros methods.Patient result of <85 ng/ml vs.An expected result of 2977 ng/ml.Biased patient results of the direction and magnitude observed could lead to inappropriate physician action.The discordant, negative result was not reported out of the laboratory and there was no report of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS BENZ 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: 5983247
• MDR Text Key: 56348739
• Report Number: 1319808-2016-00017
• Device Sequence Number: 1
• Product Code: JXM
• 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: 09/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2017
• Device Catalogue Number: 6801989
• Device Lot Number: 1523-28-5023
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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