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	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The customer complained of false negative benz benzodiazepines plus results for 4 patient urine samples on a cobas 6000 c (501) module serial number (b)(4).Of the data provided, there was a discrepant benz result for 1 patient urine sample.The benzodiazepines result was negative on the c 501 module.The physician questioned the result and requested confirmation testing as the patient was taking clonazepam.The aminoclonazepam result was 156 ng/ml with the medmatch mass spectrophotometry using the same sample.According to product labeling, a 7-aminoclonazepam result of 144 ng/ml or greater should yield a positive result.There was no allegation of an adverse event.The product labeling states "many benzodiazepines appear in the urine largely as the glucuronidated conjugate.Glucuronidated metabolites may have more or less cross-reactivity than the parent compound." the customer declined a service visit.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: 7792458
• Report Number: 1823260-2018-02746
• Device Sequence Number: 1293277
• 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
• Report Date (Section B): 08/17/2018

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 Catalogue Number: 04490789190
• Device Lot Number: 279762
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2018
• Initial Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMLODIPINE; ASPIRIN; ATENOLOL; CLONAZEPAM; CO Q-10; CYCLOBENZAPRINE; GABAPENTIN; KRILL OIL; MULTIVITAMIN; PRAVASTIN; RELION PRIME
• Patient Age: 67 YR
• Patient Weight: 88