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

Catalog Number	04939417190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the c502 analyzer is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received a questionable result for one patient urine sample tested with online dat benzodiazepines ii on a cobas 8000 c 502 module.The sample initially resulted in a positive benzodiazepines value.The value was questioned.Confirmation testing of the sample was performed using a gas chromatography mass spectrometry (gc/ms) method at another site and the benzodiazepines result was negative.The negative result was deemed correct.
Additional Manufacturer Narrative
The field service engineer determined the customer was calibrating with the wrong calibrator.The instrument was checked.The gear pump pressure was adjusted.Mechanism checks were performed and controls were run.The investigation determined the service actions resolved the issue.The issue was related to the use of incorrect calibrator material.

• 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: 22815977
• Report Number: 1823260-2025-02507
• Device Sequence Number: 18331971
• Product Code: JXM
• UDI-Device Identifier: 04015630999347
• UDI-Public: 04015630999347
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 09/12/2025

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 Catalogue Number: 04939417190
• Device Lot Number: 839714
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 08/27/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 09/12/2025
• 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
• Patient Sex: Female