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

Catalog Number	08056919190
Medical Device Problem Codes	False Negative Result (1225); Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas pro c 503 analytical unit is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable benz benzodiazepines plus results from one urine patient sample tested on the cobas pro c 503 analytical unit.The initial result was reported outside of the laboratory.The doctor questioned the result which prompted the rerun of the patient sample.The patient sample was sent for confirmatory testing to another laboratory that uses mass spectrometry.On (b)(6) 2023, the initial result from the analyzer was -131 mabs (negative).On (b)(6) 2023, the patient sample tested positive for two metabolites in mass spectrometry: oxazepam (271 ng/ml) and temazepam (4093 ng/ml).On (b)(6) 2023, the first repeat result of the aliquoted patient sample was -124 mabs (negative).The second repeat result of the aliquoted patient sample was -122 mabs (negative).The third repeat result of the aliquoted patient sample was -119 mabs (negative) the positive result was deemed correct. .
Additional Manufacturer Narrative
The investigation reviewed the calibration performed on 09-may-2023; no alarms were noted.The investigation reviewed the qc recovery; the results were within specifications.The investigation reviewed the alarm trace.The trace had abnormal aspiration alarms on the date of the event.This can be an indication of poor sample quality.
Additional Manufacturer Narrative
Medwatch field "lot no" was updated.The field application specialist (fas) explained to the customer that the reported benzodiazepine plus assay is a screening test and that this assay does not detect glucuronidated forms of certain benzodiazepines.Product labeling states: "benzodiazepines plus provides only a preliminary analytical test result.A more specific alternate chemical method must be used in order to obtain a confirmed analytical result.Gas chromatography¿mass spectrometry (gc¿ms) is the preferred confirmatory method.Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are used." "analytical specificity - many benzodiazepines appear in the urine largely as the glucuronidated conjugate.Glucuronidated metabolites may have more or less cross-reactivity than the parent compound." the investigation determined the field application specialist's actions resolved the issue.

• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17269564
• Report Number: 1823260-2023-02183
• Device Sequence Number: 17632491
• Product Code: JXM
• UDI-Device Identifier: 07613336170502
• UDI-Public: 07613336170502
• Combination Product (Y/N): N
• 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,Followup
• Report Date (Section B): 09/14/2023

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: 635345
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2023
• Supplement Date Received by Manufacturer: 08/29/2023; 09/07/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/07/2023; 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 59 YR
• Patient Sex: Female