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	09/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 (ul) v's serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable bnz2 result from one urine forensic patient sample tested on the cobas 6000 c 501 (ul) v.On (b)(6) 2024: the initial result from the module was 142 (positive).On (b)(6) 2024: the repeat result from a xevo analyzer that uses the liquid chromatography - mass spectrometry (lc-ms) laboratory method was "negative".The repeat result was deemed correct.The initial result was not reported outside the laboratory as they perform reflex testing for forensic patient samples.
Additional Manufacturer Narrative
The qc recovery was acceptable.The customer confirmed the correct handling of the reagent, the use of the correct calibrator, and the acceptable sample handling.Patient diagnosis and medication list were requested for further investigation but the customer was unable to provide this information.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: 20483061
• Report Number: 1823260-2024-03017
• Device Sequence Number: 11786074
• Product Code: JXM
• UDI-Device Identifier: 04015630999347
• UDI-Public: 04015630999347
• Combination Product (Y/N): Y
• 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): 12/13/2024

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: 79950801
• 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: 09/26/2024
• Supplement Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 12/13/2024
• 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 Age: 38 YR
• Patient Sex: Female