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

Catalog Number	08056927190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of a questionable false positive online dat benzodiazepines ii result from the cobas pro ssu.The patient had an initial positive result.The repeat result by lc/ms was negative for benzodiazepines including so-7-aminoclonazepam, so-7-aminoflunitrazepam, so-alpha hydroxyalprazolam, so-lorazepam, so-nordiazepam, so-oxazepam, and so-temazepam.This result that was deemed to be correct.The results were not released outside of the laboratory.The sample was repeated as the customer has had other initially positive drug screenings that were repeated and found to be negative.
Additional Manufacturer Narrative
The cobas pro ssu serial number is (b)(6).A field service engineer (fse) performed a system check, sample probe adjustments, checked the sonic wash station, rinse level adjustments were checked, and reagent probe alignments.All checks and a precision run were within specifications.All controls are acceptable to the customer, and the system is performing according to specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch field d10 concomitant medical products and therapy dates (excludes treatment of event) was updated.The field service engineer stated that the patient specimen was recollected and tested negative for all drugs.The patient had a cesarean section.The investigation was unable to determine a direct root cause.

• 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: 22080634
• Report Number: 1823260-2025-01596
• Device Sequence Number: 9338039
• Product Code: JXM
• UDI-Device Identifier: 07613336121054
• UDI-Public: 07613336121054
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 06/25/2025

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: 08056927190
• Device Lot Number: 7718733
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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: IBUPROFEN 800 MG; LEVIETRIRACETAM (KEPPRA) OF 750 MG
• Patient Sex: Unknown