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

Catalog Number	08056960190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The qc recovery data provided was acceptable but showed some imprecision.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bilirubin total gen.3 results for 9 patient samples on a cobas c 503 analytical unit.The customer observed high total bilirubin results which prompted them to repeat patient samples on another c503 analyzer with a different reagent lot.For sample 1, the initial total bilirubin result was 26.7 umol/l.The sample was repeated on another analyzer and the result was 7.9 umol/l.For sample 2, the initial total bilirubin result was 34.7 umol/l.The sample was repeated on another analyzer and the result was 12.3 umol/l.For sample 3, the initial total bilirubin result was 43 umol/l.The sample was repeated on another analyzer and the result was 13.6 umol/l.For sample 4, the initial total bilirubin result was 34.9 umol/l.The sample was repeated on another analyzer and the result was 4.7 umol/l.For sample 5, the initial total bilirubin result was 21.9 umol/l.The sample was repeated on another analyzer and the result was 11.2 umol/l.The customer also performed precision testing on the affected analyzer using patient samples.For sample 6, the initial total bilirubin result was 22.4 umol/l.The sample was repeated on the same analyzer twice and the results were 14.8 umol/l and 15.1 umol/l.For sample 7, the initial total bilirubin result was 25.3 umol/l.The sample was repeated on the same analyzer 5 times and the results were 8.83 umol/l, 57.7 umol/l, 2.91 umol/l, 1.86 umol/l, and 4.19 umol/l.For sample 8, the initial total bilirubin result was 21.4 umol/l.The sample was repeated on the same analyzer 3 times and the results were 4.97 umol/l, 8.53 umol/l, and 4.59 umol/l.For sample 9, the initial total bilirubin result was 27.6 umol/l.The sample was repeated on the same analyzer twice and the results were 17.2 umol/l and 16.4 umol/l.
Additional Manufacturer Narrative
The alarm trace showed multiple sample short, abnormal liquid level, and abnormal sample probe aspiration errors.The field service engineer (fse) found that the water pressure had slightly increased.The customer replaced the reagent pack with a different lot number, and the issue was resolved.The investigation determined the event was consistent with a handling, storage, or shipping issue with the particular reagent pack.

• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22904124
• Report Number: 1823260-2025-02631
• Device Sequence Number: 8018151
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: 06/30/2026
• Device Catalogue Number: 08056960190
• Device Lot Number: 845890
• 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: 08/07/2025
• Supplement Date Received by Manufacturer: 11/11/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/02/2025
• 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 Sex: Unknown