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 06/22/2018

Event Type  malfunction  

Event Description

The customer is having issues detecting clonazepam in a patient sample using the benzodiazepines plus (benz) assay on a cobas 6000 c (501) module.The customer complained of a false negative result for 1 patient sample tested for benz.Previous patient samples have had similar issues.Using the 300 ng/ml cutoff, the customer got an initial benz result of [-] 34, negative.The customer reported out the negative result to the physician, but they informed the physician they were doing additional confirmation testing.The sample was sent to an outside laboratory and the sample was confirmed positive for clonazepam with a result of 1124 ng/ml.The patient sample was tested on the cobas c501 on (b)(6) 2018 using the 100 ng/ml cutoff and the results were positive.The specific results were 27 and 26 both results with a data flag.The customer deemed these positive results as correct.There was no adverse event.The cobas c501 serial (b)(4).The investigation is currently ongoing.

Manufacturer Narrative

The investigation was unable to find a definitive root cause.

• Brand Name: BENZ BENZODIAZEPINES PLUS
• Type of Device: ENZYME IMMUNOASSAY, BENZODIAZEPINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7727794
• MDR Text Key: 115675040
• Report Number: 1823260-2018-02332
• Device Sequence Number: 1
• Product Code: JXM
• UDI-Device Identifier: 04015630997718
• UDI-Public: 04015630997718
• Combination Product (y/n): N
• PMA/PMN Number: K043327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• 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
• Date Manufacturer Received: 06/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 76