MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BIL-D GEN.2; BILIRUBIN, DIAZO COLORIMETRY

Catalog Number	08056951190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable bil-d gen.2 results from the cobas pure c303 analyzer.The customer alleged the results for newborn patients undergoing phototherapy were significantly higher on the cobas pure c 303 system than the results from a competitor systems (e.G.Siemens) or from a cobas c 501 or cobas integra 400 plus.The following example was provided: sample 1 (neonate): the result from the cobas c 303 was 1.13 mg/dl.The result from a cobas c503 was 1.02 mg/dl.The result from a cobas c501 was 0.90 mg/dl.The result from a non-roche method was 0.34 mg/dl.The questionable results were not reported outside of the laboratory.The non-roche results were believed to be correct.
Additional Manufacturer Narrative
The reagent lot number was 877868.The expiration date was not provided.The investigation is ongoing.
Additional Manufacturer Narrative
Medwatch fields d1-d4, g1, and g4 were updated.The investigation was unable to determine a specific root cause.There was no product problem identified.Per product labeling: under the influence of intense blue light in vivo; e.G., during phototherapy, circulating bilirubin is partly transformed into a water-soluble isomer called photobilirubin, a potential substrate for bilirubin tests.This photobilirubin fraction is rapidly eliminated in vivo, but is detected by bild2 and may lead to falsely elevated bilirubin results.For diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.

• Brand Name: BIL-D GEN.2
• Common Device Name: BILIRUBIN, DIAZO COLORIMETRY
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 23840135
• Report Number: 1823260-2025-05215
• Device Sequence Number: 18596157
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K123965
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

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: 08056951190
• Device Lot Number: 877868
• 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: 12/05/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 12/18/2025
• Supplement Report FDA Received Date: 02/12/2026
• 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