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

Catalog Number 04490789190

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Unique identifier (udi)# (b)(4).

Event Description

The customer complained of a false negative result for 1 patient sample tested for benz benzodiazepines plus (benz) on a cobas 6000 c (501) module which was later confirmed positive by the reference method.The sample was initially tested for benz at another laboratory, site a, on a cobas c501 on (b)(6) 2017 and a negative result was obtained, specific result not provided.This result was questioned by the physician based on the patient being prescribed clonazepam.The sample was sent to the laboratory, site b, for confirmation testing.Liquid chromatography¿mass spectrometry (lc/ms) testing for 7-aminoclonazepam was performed on (b)(6) 2017 and a result of 1451.166 ng/ml was obtained.This is a confirmed positive result and this result was deemed to be correct.The customer tested for benz on (b)(6) 2017 on their cobas c501, using a benz cutoff of 300, and a negative result was obtained (-93 mabs).The customer stated that they have not had any recent issues with the analyzer or with any qc or other patient results.It was noted that the sample in question was stored refrigerated for greater than the recommended 5 days recommended per product labeling.Site a¿s cobas c501 serial number was (b)(4).The benz reagent lot that was used at site a was 20897601 with an expiration date of 31-oct-2018.A field engineering specialist visited site site a and performed a precision check.He did not mention finding any problems and stated the patient sample was probably the cause of the inaccuracy.Site b¿s cobas c501 serial number was (b)(4).Lot information as well as initial reporter correspond to site b.Site b refused a service visit as they felt the issue was sample related.It was noted that site b was using expired lots of calibrators and controls.There were no adverse events.The investigation is currently ongoing.

Manufacturer Narrative

Retention testing of benz reagent lots 250726 and 208976 was performed.7-aminoclonazepam recovery was acceptable a general reagent issue can be excluded.For the patient sample in question, it is believed an unknown interference might have caused the false negative result despite the presence of 7-aminoclonazepam.A possible root cause could be related to how the sample was collected, for example the use of a catheter for collection or addition of disinfectants or cleaning agents in the sample.

Manufacturer Narrative

Upon further investigation it was determined that the initial negative benz results are confirmed correct.Using high-performance liquid chromatography-electrospray ionisation tandem mass spectrometry (hplc-esi-ms) testing method, no 7-aminoclonazepam could be found in the patient sample.Neither could metabolites nor degradation substances be detected in the patient sample from the customer.A root cause for the high lc-ms result from the customer site could not be explained.

• 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: 7176325
• MDR Text Key: 96837138
• Report Number: 1823260-2018-00090
• 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,Followup
• Report Date: 04/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 04490789190
• Device Lot Number: 25072601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/18/2017
• 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
• Patient Age: 55 YR