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

Catalog Number	04490789190
Medical Device Problem Codes	False Negative Result (1225); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number for the c501 module is (b)(6).The serial number for the c303 module is (b)(4).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable benzodiazepines plus results for 2 patient samples on a cobas 6000 c (501) module compared to a cobas c303 module.Patient sample 1: the initial result was 200 mabs, performed on a cobas c303 module.The sample was repeated on the same module and the result was 201 mabs.The positive results were questioned due to a test flag in the instrument manager.The sample was repeated on the c501 module and the result was 9 mabs.The negative result from the c501 was reported to the provider but the customer is unsure which result is correct.Confirmation results (gcms) for patient sample 1: the nordiazepam result was 16 ng/ml with a cutoff of 10 ng/ml.The oxazepam result was 61 ng/ml with a cutoff of 10 ng/ml.The temazepam was 41 ng/ml with a cutoff of 10 ng/ml.Patient sample 2: the initial result was 358 mabs, performed on a cobas c303 module.The sample was repeated on the same module and the result was 362 mabs.The positive results were questioned due to a test flag in the instrument manager.The sample was repeated on the c501 module and the result was 27 mabs.Initially, the positive results were reported outside of the laborator, but a corrected report with the negative result was sent.The specimen type used for testing was urine.
Additional Manufacturer Narrative
The customer declined a service visit.Calibration and qc data were acceptable.The analyzer alarm trace contained an abnormal sample aspiration alarm.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: BENZODIAZEPINES PLUS
• Common Device Name: ENZYME IMMUNOASSAY, BENZODIAZEPINE
• 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: 18443270
• Report Number: 1823260-2024-00027
• Device Sequence Number: 6751745
• Product Code: JXM
• UDI-Device Identifier: 04015630997718
• UDI-Public: 04015630997718
• Combination Product (Y/N): Y
• Initial Reporter State: MO
• 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): 04/03/2024

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 Expiration Date: 09/30/2024
• Device Catalogue Number: 04490789190
• Device Lot Number: 69268001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 03/20/2024
• Initial Report FDA Received Date: 01/04/2024
• Supplement Report FDA Received Date: 04/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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