MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795419190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 8000 c702 module serial number was 2195-05.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable total bilirubin (bil-t gen 3) results from the cobas 8000 c702 module.The result was 9.9 mg/dl on another analyzer and the result on this analyzer was 0.5 mg/dl.The customer also provided a result of 10.4 mg/dl.The customer reported a result of 10.2 mg/dl that was believed correct.
Additional Manufacturer Narrative
The field service engineer checked the analyzer and could not determine a cause.He ran precision testing that passed, checked and adjusted the sample probe, and checked the rinsing.He found small damage to the vacuum tubing which he replaced.He checked and adjusted the gear pump pressure and repeated the precision testing that passed.The customer ran calibrations and qc that passed.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: BILT3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• 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: 18865253
• Report Number: 1823260-2024-00707
• Device Sequence Number: 8173029
• Product Code: CIG
• UDI-Device Identifier: 04015630928903
• UDI-Public: 04015630928903
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K131544
• 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): 04/05/2024

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: 05795419190
• Device Lot Number: 725793
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/22/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/05/2024
• 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: Female