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

Catalog Number	08056919190
Medical Device Problem Codes	False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter received questionable benz benzodiazepines plus results from about three patient samples tested on the cobas c 303 analytical unit - emc.The reporter stated there was a possible interference issue with benzodiazepine plus testing.The reporter was able to provide one example of a questionable result: the initial result was reported outside of the laboratory.The provider ordered reflex testing as the results were flagged as presumptive positive.The initial result from the analyzer was "positive".The repeat result from another laboratory using the liquid chromatography-mass spectrometry (lc¿ms) laboratory method was "negative".The repeat result was deemed correct. .
Additional Manufacturer Narrative
The serial number of the customer's cobas c 303 analytical unit - emc is (b)(6).The field applications specialist (fas) investigated the event and noted that the customer did not mix the reagent pack before it was used.The customer stated that the issue was resolved when they loaded a new reagent pack and the patient sample was rerun.Product labeling states "carefully invert reagent container several times prior to use to ensure that the reagent components are mixed" the field service engineer (fse) inspected the analyzer and could not determine the cause of the event.He then loaded a new reagent pack which was fully inverted 10 times before use.He performed a precision test using urine quality control (qc) and a comparison test between the analyzer and the cobas pro using qc and patient samples.The investigation is ongoing.
Additional Manufacturer Narrative
After service, no further issues were reported by the customer.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: 19201365
• Report Number: 1823260-2024-01302
• Device Sequence Number: 20868761
• 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): 05/31/2024

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: 04/29/2024
• Supplement Report FDA Received Date: 05/31/2024
• 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