MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE DAT BENZODIAZEPINES II; BENZODIAZEPINE GROUP IVD, KIT, ENZYME IMMUNOASSAY (EIA)

Catalog Number	08056927190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the first c 503 analyzer is (b)(6) and the serial number of the second c 503 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received false positive results for three patient samples tested with online dat benzodiazepines ii on two cobas c 503 analytical unit analyzers.The first patient's sample resulted in a benzodiazepines value of 76.5 mabs (positive) when tested on the first c 503 analyzer and it resulted in a value of 59.5 mabs (positive) when tested on the second c 503 analyzer.The sample was sent to another laboratory for gc/ms confirmation testing and the result was negative (see attachment for full results).The second patient's sample resulted in a benzodiazepines value of 12.5 mabs (positive) when tested on the first c 503 analyzer on (b)(6) 2025 and it resulted in a positive when tested on the second c 503 analyzer on (b)(6) 2025.The sample was sent to another laboratory for gc/ms confirmation testing and the result was negative (see attachment for full results).The third patient's sample resulted in a benzodiazepines value of 10.8 mabs (positive) when tested on the first c 503 analyzer on (b)(6) 2025 and it resulted in a value of 20.9 mabs (positive) when tested on the second c 503 analyzer on (b)(6) 2025.The sample was sent to another laboratory for gc/ms confirmation testing and the result was negative (see attachment for full results).The negative gc/ms results for all three patients were deemed correct.
Additional Manufacturer Narrative
No patient samples were available for investigation.A penecillin g interference is unlikely as 100 ug/ml with 75 ng/ml nordiazepam showed no interference.Interference with oxytocin was tested at 100 g/ml and in the presence of 75 ng/ml nordiazepam.Both approaches were completely inconspicuous.Typical injectable solutions are prepared with approximately 20 g/ml leading to 20 g/ml concentrations in the circulation and consequently in the urine.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ONLINE DAT BENZODIAZEPINES II
• Common Device Name: BENZODIAZEPINE GROUP IVD, KIT, ENZYME IMMUNOASSAY (EIA)
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22493339
• Report Number: 1823260-2025-02131
• Device Sequence Number: 18106142
• Product Code: JXM
• UDI-Device Identifier: 07613336121054
• UDI-Public: 07613336121054
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K221765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 10/30/2025

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: 04/30/2026
• Device Catalogue Number: 08056927190
• Device Lot Number: 80283701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 10/13/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: REFER TO THE ATTACHMENT FOR ALL PATIENT MEDICATION
• Patient Age: 30 YR
• Patient Sex: Female