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

Catalog Number	04490789190
Medical Device Problem Code	False Positive Result (1227)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c501 module serial number was (b)(6).H3 other text : na.
Event or Problem Description
We received an allegation of discrepant results for 1 patient sample tested for benzodiazepines plus (benz) on a cobas 6000 c (501) module.The result from the c 501 module was "positive." the specific result was not provided.The positive result was reported outside of the laboratory where it was questioned.The sample was not repeated on the c501 module.The sample was sent for testing by liquid chromatography-mass spectrometry (lc/ms) and the result was "negative." the negative result was believed to be correct.
Additional Manufacturer Narrative
The investigation determined the event was due to a reagent handling issue at the customer site.The customer was not inverting the reagent pack.Product labeling states: "carefully invert reagent container several times prior to use to ensure that the reagent components are mixed." the customer confirmed that after they began inverting the reagent prior to use and recalibrated, the issue was resolved.

• 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: 17339496
• Report Number: 1823260-2023-02317
• Device Sequence Number: 6903384
• 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,Followup
• Report Date (Section B): 07/23/2023

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: 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): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 07/24/2023
• 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: 37 YR
• Patient Sex: Female