MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE DAT BENZODIAZEPINES PLUS; BENZODIAZEPINE ENZYME IMMUNOASSAY

Catalog Number	08056919190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).It was determined that the two versions of the benz assay are not directly comparable.The new version of the assay contains beta-glucuronidase enzyme while the old version does not.To be compared, the samples would need to be treated with beta glucuronidase when using the old version.Both assays have a different cross-reactivity to glucuronides.Per the benz product labeling, "many benzodiazepines appear in the urine largely as the glucuronidated conjugate.Glucuronidated metabolites may have more or less cross-reactivity than the parent compound." per the bnz2 product labeling, "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 presence of -glucuronidase enzyme enhances the benzodiazepines ii assay cross-reactivity to some of the glucuronidated metabolites." no product performance issue was identified.
Event or Problem Description
There was an allegation of questionable benz benzodiazepines plus urine results for 4 patient samples on a cobas pro c 503 analytical unit.The customer stated that they had been performing a correlation study between the benz reagent and the new reagent version.Four patient samples gave a negative benz result and a positive result with the new reagent version.The samples were sent out for mass spectrometry confirmation testing and the results were positive.The confirmation results were deemed correct.One of the patients' information was provided.

• Brand Name: ONLINE DAT BENZODIAZEPINES PLUS
• Common Device Name: BENZODIAZEPINE ENZYME IMMUNOASSAY
• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17374771
• Report Number: 1823260-2023-02403
• Device Sequence Number: 3863574
• Product Code: JXM
• UDI-Device Identifier: 07613336170502
• UDI-Public: 07613336170502
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043327
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/21/2023

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: 01/31/2024
• Device Catalogue Number: 08056919190
• Device Lot Number: 63534601
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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: AMBIEN; ATENOLOL; BUPROPION; DULOXETINE; GABAPENTIN; NORCO; NUCYNTA; PERCOCET; QUTENZA; XANAX
• Patient Age: 67 YR
• Patient Sex: Female