MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILIRUBIN TOTAL GEN. 3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c311 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant low result for 1 patient neonate sample tested for bilirubin total gen.3 (bil-t) on a cobas c 311 analyzer.The initial result was 1.3 mg/dl.The sample was repeated as the result was "significantly" different than the previous result for this patient.The repeat from a different c311 analyzer was 13.2 mg/dl.This result was believed to be correct.
Additional Manufacturer Narrative
It was found that the bil-t application decimal placement was incorrect due to the h2o calibrator set point.The h2o calibrator was downloaded when the field application specialist (fas) installed a new direct bilirubin application.The h2o calibrator set point was different than the previous set point for bil-t.The set point was corrected and the decimal point for bil-t was properly changed.Calibration and qc were acceptable.The customer has had no further issues.The investigation did not identify a product problem.

• Brand Name: BILIRUBIN TOTAL GEN. 3
• 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: 21105869
• Report Number: 1823260-2025-00057
• Device Sequence Number: 15649049
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• 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): 01/22/2025

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: 09/30/2025
• Device Catalogue Number: 05795397190
• Device Lot Number: 78538801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/18/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 01/22/2025
• 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 Age: 9 DA
• Patient Sex: Male