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

Catalog Number	08056919190
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service engineer (fse) performed a baseline check on all probes, rinse nozzles, pipettors, and water pressures.The fse cleaned the tubing of both sample probes and verified all pressures and adjustments.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable benz benzodiazepines plus results for 1 patient on a cobas pro c 503 analytical unit compared to a triage meter and gc/ms testing.On (b)(6) 2023, the patient had 2 separate urine samples that tested negative for benz on the c503 analyzer.The results were reported outside of the laboratory.The doctor questioned the results as the patient is currently taking a benzodiazepine medication and the samples were repeated on another analyzer.The samples were repeated on a triage meter.The first sample had a result of 153 ng/dl, interpreted as positive, and the second sample had a result of 439 ng/dl, interpreted as positive.On (b)(6) 2023, the patient had a third urine sample collected that tested negative for benz on the c503 analyzer.The sample was repeated on a triage meter and the result was 44 ng/dl, interpreted as positive.All three samples were also sent out to a reference laboratory and all three samples gave positive results via gc/ms testing.The positive results were deemed correct.The c503 analyzer serial number is (b)(4).
Additional Manufacturer Narrative
The patient is currently taking lorazepam.Lorazepam is metabolized and mainly present in the urine as glucuronides.The benz plus assay does not contain glucuronidase enzyme, therefore, the lorazepam glucuronides are not detected by the assay without pre-treatment with glucuronidase.Per 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." it was determined that the assay is working according to specifications.

• 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: 16522855
• Report Number: 1823260-2023-00762
• Device Sequence Number: 6449291
• 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,Followup
• Report Date (Section B): 04/06/2023

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: 02/10/2023
• Supplement Date Received by Manufacturer: 03/09/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 04/06/2023
• 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: ACETAMINOPHEN; ASPIRIN; ATORVASTATIN; BISACODYL; CARBAMAZEPINE; CITALOPRAM; LAMOTRIGINE; LISINOPRIL; LORAZEPAM; PANTOPRAZOLE; SODIUM BISPHOSPHATE; TAMSULOSIN; TRAZODONE; ZIPRASIDONE
• Patient Age: 70 YR
• Patient Sex: Male