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

Catalog Number	04939417190
Medical Device Problem Codes	False Positive Result (1227); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer stated they used additional reagent lot numbers: (763338 and 799508) since on (b)(6) 2024.The c501 modules' serial numbers were (b)(6).The customer stated they had no issues until they switched to the new version of the bnz2 assay.Qc was within the acceptable ranges.During troubleshooting, the customer mentioned that they have a machine that swirls the reagent packs.The investigation is ongoing.
Event or Problem Description
We received an allegation about questionable high results for 1 patient urine sample tested with online dat benzodiazepines ii (bnz2) assay on two different cobas 6000 c (501) modules when compared to a liquid chromatography¿mass spectrometry (lc/ms) method.Initial result: positive (tested on the 1st c501 module.The customer stated that they noticed questionable high bnz2 results since on (b)(6) 2024.The sample was sent out to a provider to be re-tested using an lc/ms method and the result was negative.The sample was then repeated on another c501 module at the customer's site and the result was positive.The negative result was deemed to be correct.
Additional Manufacturer Narrative
The sample was collected in a urine cup and poured into a glass tube.The customer was unable to provide further information.The field service engineer was dispatched to the customer's site but the customer refused the service as they were switching to another vendor.The investigation did 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21242813
• Report Number: 1823260-2025-00241
• Device Sequence Number: 20984029
• Product Code: JXM
• UDI-Device Identifier: 04015630999347
• UDI-Public: 04015630999347
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 02/14/2025

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: 04939417190
• Device Lot Number: 80283601
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/12/2025
• Initial Report FDA Received Date: 01/27/2025
• Supplement Report FDA Received Date: 02/14/2025
• 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: Unknown