MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BENZ BENZODIAZEPINES PLUS; ENZYME IMMUNOASSAY, BENZODIAZEPINE

Catalog Number 04490789190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

The customer requested information related to the relationship between benz benzodiazepines plus (benz) run on a cobas 6000 c (501) module and the drug clonazepam.The customer is a toxicologist who is gathering information for a criminal case he will be testifying in.The customer wanted sensitivity and specificity information related to clonazepam and the benz test.The customer was interested in the cross-reactivity between clonazepam and the metabolite against which benz is measured which is nordiazepam.The customer stated 1 patient urine sample was tested for benz and the result was "positive." the actual result was not provided.The sample was repeated by gas chromatography¿mass spectrometry (gc/ ms) method and the result was "negative." the actual result was not provided.The positive result was reported outside of the laboratory.No adverse event occurred due to the result from the device.The c501 module serial number was not provided.The customer was provided with cross-reactivity information from product labeling.Per product labeling the benz assay "provides only a preliminary analytical test result.A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.Gc/ms is the preferred confirmatory method.Clinical consideration and professional judgement should be applied to any drug of abuse test result, particularly when preliminary positive results are used." the cross-reactivity for clonazepam is 68%.The cutoff for benz is 100 ng/ml.It would take 148 ng/ml of clonazepam to cause reactivity comparable to 100 mg/dl of the target drug nordiazepam.At the 100 ng/ml cutoff, it would take 148 ng/ml of clonazepam (more than the target drug of nordiazepam at cutoff) to cause a positive result.

Manufacturer Narrative

A specific root cause was not identified.Additional information was requested for investigation but was not provided.Trending was performed on this type of complaint and no abnormal trend was identified.During a review for this customer site, there were no similar past complaints on any like instrument for the past 12 months.

• Brand Name: BENZ BENZODIAZEPINES PLUS
• Type of Device: ENZYME IMMUNOASSAY, BENZODIAZEPINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 7078956
• MDR Text Key: 94747384
• Report Number: 1823260-2017-02819
• Device Sequence Number: 1
• Product Code: JXM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04490789190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1