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

Catalog Number	08056960190
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas e 402 analytical unit serial number is (b)(6).The calibration and qc results were within the specified ranges.The alarm trace had abnormal aspiration (aample pipetter), sample clot detection, sample foam detection, and sample short errors.These are indicators of possible poor sample quality.The field service engineer inspected the analyzer and no hardware issues were detected.He performed mechanical and instrument checks and verified the analyzer's performance with a successful precision check.The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable bilirubin total gen.3 assay results from three samples from the same patient tested on the cobas e 402 analytical unit.On (b)(6) 2025: the initial result of the first patient sample from a heel stick was 14.3 mg/dl.The reporter requested the collection of a second patient sample as the hemolysis index was 363.The initial result of a second patient sample from a heel stick was 21.1 mg/dl.The reporter deemed this result erroneous.The result of the third patient sample obtained by venipuncture was 14.9 mg/dl.The hemolysis index was noted to be significantly lower.On (b)(6) 2025: the repeat result of the second patient sample was 12.9 mg/dl.The care provider questioned this result.The result of a fourth patient sample from another laboratory was 16.2 mg/dl and was deemed correct.
Additional Manufacturer Narrative
Medwatch field d4 expiration date was updated.The customer confirmed that the patient sample was icteric and hemolytic.The investigation determined that a sample handling issue (hemolyzed patient sample) had caused the event.The investigation determined that the customer's actions (recollecting a new patient sample) resolved the issue.

• 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: 22112950
• Report Number: 1823260-2025-01660
• Device Sequence Number: 4250923
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/11/2025

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: 04/30/2026
• Device Catalogue Number: 08056960190
• Device Lot Number: 823599
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 06/23/2025
• Initial Report FDA Received Date: 05/30/2025
• Supplement Report FDA Received Date: 07/11/2025
• 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: 2 DA
• Patient Sex: Unknown