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

Catalog Number	04490789190
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	02/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with benzodiazepines plus on a cobas 6000 c (501) module (serial number (b)(4)).The sample initially resulted in a benzodiazepines value of -287 mabs (negative) and this value was reported outside of the laboratory.The sample was automatically repeated by the analyzer, resulting in a value of 87 mabs (positive).The sample was repeated an additional time, resulting in a value of 88 mabs (positive).The positive value of 87 mabs was deemed correct by the customer and a corrected report was issued.The sample was repeated using the gc/ms benzodiazepines method, and the result was negative.
Additional Manufacturer Narrative
The field service engineer could not determine a cause.The instrument was checked including the fluidics.The rinse mechanism was adjusted.The mixers, vacuum pump, and gear pump were checked.The reagent volume dispense, probe alignments, water pressure, cell blank, and photometer were also checked.The last calibration performed on 06-jan-2023 was ok and there were no alarms.Quality controls were acceptable.The investigation could 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16490800
• Report Number: 1823260-2023-00687
• Device Sequence Number: 6844403
• Product Code: JXM
• UDI-Device Identifier: 04015630997718
• UDI-Public: 04015630997718
• 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
• Report Date (Section B): 03/06/2023

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 Expiration Date: 05/31/2023
• Device Catalogue Number: 04490789190
• Device Lot Number: 57478601
• 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: 02/08/2023
• Initial Report FDA Received Date: 03/06/2023
• 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: 29 YR
• Patient Sex: Female