MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ONLINE DAT BENZODIAZEPINES PLUS; BENZODIAZEPINE ENZYME IMMUNOASSAY

Catalog Number	08056919190
Medical Device Problem Codes	False Positive Result (1227); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter questioned positive results for 2 patient urine samples tested for online dat benzodiazepines plus (benz) on a cobas c 503 analytical unit.Patient 1 result from the c503 analyzer was positive.On (b)(6) 2024 patient 2 result from the c503 analyzer was positive.The samples were sent to an external laboratory using liquid chromatography-mass spectrometry (lc/ms) and the results for both samples were negative.The negative results were believed to be correct.
Additional Manufacturer Narrative
The field service engineer (fse) did not identify any instrument issues.The performance of the instrument was verified.The field application specialist (fas) found the reagent pack had not been mixed prior to calibration or use of the pack.The issue was resolved by loading a new reagent pack that had been mixed and repeating the samples.Precision testing was acceptable.Product labeling states: "carefully invert reagent container several times prior to use to ensure that the reagent components are mixed." the investigation did not identify a product problem.

• Brand Name: ONLINE DAT BENZODIAZEPINES PLUS
• Common Device Name: BENZODIAZEPINE ENZYME IMMUNOASSAY
• 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: 19175459
• Report Number: 1823260-2024-01265
• Device Sequence Number: 20418507
• Product Code: JXM
• UDI-Device Identifier: 07613336170502
• UDI-Public: 07613336170502
• Combination Product (Y/N): Y
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K043327
• 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): 05/29/2024

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: 08056919190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2024
• Supplement Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 04/24/2024
• Supplement Report FDA Received Date: 05/29/2024
• 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 Sex: Unknown