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	11/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).Section e1, initial reporter email address provided as: (b)(6).
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient sample tested for bil-d gen.2 (bild2) on a cobas c 503 analytical unit.The initial result was 11.8 umol/l.The repeat result was 8.6 umol/l.The sample was repeated on a different instrument with a result of 3.5 umol/l.The customer performed daily maintenance on another cobas instrument and repeated the sample with a result of 3.47 umol/l.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Precision test results did not show any ultrasonic mixer or sample pipetting issues.For patient 1: an abnormal reaction was observed on the reaction monitor data provided for the result of 3.47 umol/l.This reaction suggests a sample quality issue or dirt in the cuvette.Patient 1 sample was centrifuged for 11 minutes at 2100 g.Based on the sample tubes used, this is not consistent with the manufacturer's recommendations.Patient one's dosage of valacyclovir is at the higher end of commonly prescribed doses.According to the package insert, valacyclovir may potentially elevate liver function tests and cause liver enzyme abnormalities, which may affect the liver's ability to process and excrete bilirubin, possibly leading to elevated bild levels, especially at high doses, where this risk may increase.Patient 2 had pneumonia.Pneumonia can trigger systemic inflammation, which may irritate the body and influence liver function, possibly leading to high bilirubin results.Regarding a decrease in the same sample upon retesting, it is most possibly attributed to the light sensitivity of bilirubin, where light exposure causes rapid degradation over time.For patient 3: an abnormal reaction was observed on the reaction monitor data provided for the result of 8.42 umol/l.This reaction suggests issues with a clogged probe, sample quality, or dirt in the cuvette.For patient 4: the difference in results may be related to light exposure and the storage conditions of the tube.Based on the information provided, hardware issues were excluded.Calibration and qc were acceptable; therefore, a reagent issue can be excluded.As the issue occurred with different patients with different pathological symptoms and taking different medications, a drug interference is not suspected.Based on the reaction monitor data, a drug interference can be excluded.The investigation determined the event was consistent with sample handling issues.
Additional Manufacturer Narrative
Discrepant bild2 results were provided for an additional 3 patient samples (patients 2, 3, and 4).On (b)(6)2025, patient 2 initial result was 15.9 umol/l.The sample was repeated twice, with results of 13.6 umol/l and 8.8 umol/l.On (b)(6) 2025, patient 3 initial result was 8.42 umol/l.The repeat result was 3.17 umol/l.On (b)(6) 2026, patient 4 initial result was 14.9 mol/l.The repeat results from the same analyzer were 5.6 mol/l, 5.5 mol/l, and 5.1 mol/l.The repeat results from another cobas analyzer were 6.8 mol/l, 5.6 mol/l, and 5.0 mol/l.Medwatch field b7 other relevant history and d10 concomitant medical product were updated.

• 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
• MDR Report Key: 23703924
• Report Number: 1823260-2025-04922
• Device Sequence Number: 10595401
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 02/20/2026

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 08056951190
• Device Lot Number: 87776801
• 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: 11/13/2025
• Supplement Date Received by Manufacturer: 12/26/2025; 02/05/2026
• Initial Report FDA Received Date: 12/03/2025
• Supplement Report FDA Received Date: 01/16/2026; 02/20/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: PATIENT 4: ATORVASTATIN; PATIENT 4: CLINDAMYCIN/LEVOFLOXACIN; PATIENT 4: DAPAGLIFOZINE; PATIENT 4: INSULIN; PATIENT 4: MORPHINE; PATIENT 4:LIRAGLUTIDE; VALACYCLOVIR
• Patient Age: 22 YR
• Patient Sex: Female