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

Catalog Number 6801989

Device Problem False Negative Result (1225)

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

Event Date 06/04/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a false negative vitros benz result (<85 ng/ml) was obtained from a patient sample based on confirmatory testing using a non-vitros method, hdlc/ms and chemiluminescence, when tested on a vitros 5600 integrated system.The most likely cause is a known limitation of the vitros benz reagent related to low cross reactivity with lorazepam glucuronide.There is no evidence to suggest that the vitros benz reagent lot 1523-30-5303 malfunctioned.

Event Description

A customer obtained an unexpected discordant vitros benz negative result using a <200 ng/ml cutoff from a urine sample from a patient suspected of accidentally ingesting lorazepam when the physician expected a positive result from the patient due to their condition, on a vitros 5600 integrated system.Patient 1 vitros result < 85 ng/ml (negative) versus an expected positive result (>200 ng/ml).Biased results of the magnitude and direction observed may lead to inappropriate physician action.The discordant vitros benz result was reported out of the laboratory.However, there was no report of treatment started, stopped, or altered based on the false negative vitros benz result 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 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: 6692692
• MDR Text Key: 79912142
• Report Number: 1319808-2017-00011
• Device Sequence Number: 1
• Product Code: JXM
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2017
• Device Catalogue Number: 6801989
• Device Lot Number: 1523-30-5303
• Other Device ID Number: 10758750001750
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2017
• Initial Date FDA Received: 07/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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