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

Catalog Number	04490789190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
The investigation was unable to find a definitive root cause.

• Brand Name: BENZ BENZODIAZEPINES PLUS
• Common Device Name: ENZYME IMMUNOASSAY, BENZODIAZEPINE
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 7727794
• Report Number: 1823260-2018-02332
• Device Sequence Number: 19086424
• Product Code: JXM
• UDI-Device Identifier: 04015630997718
• UDI-Public: 04015630997718
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 04490789190
• Device Lot Number: 25072601
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 06/29/2018
• Initial Report FDA Received Date: 07/27/2018
• Supplement Report FDA Received Date: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 76