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

Catalog Number	08056951190
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the analyzer was (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable bil-d gen.2 results for two patient samples tested on a cobas c 503 analytical unit.Sample 1: on (b)(6) 2025: the initial result was 0.569 mg/dl.The sample was repeated 5 times and generated results of 0.187 mg/dl, 0.187 mg/dl, 0.183 mg/dl, 0.183 mg/dl, and 0.184 mg/dl.The sample was repeated 5 more times and generated results of 0.190 mg/dl, 0.198 mg/dl, 0.191 mg/dl, 0.192 mg/dl, and 0.191 mg/dl.Sample 2: on (b)(6) 2025: the initial result was 3.460 mg/dl.The repeat result was 0.112 mg/dl.
Additional Manufacturer Narrative
A reagent issue is not likely since the qcs and calibration data are inconspicuous.An analysis of the picture of the affected tube confirms poor sample quality, most likely due to improper handling.The gel layer seems not to be properly separated and is contaminated with erythrocytes.The investigation determined the issue was due to pre-analytical handling issues at the customer site.Correct pre-analytic sample handling is within the customer's responsibility.There is no evidence to suggest a malfunction of the device.
Additional Manufacturer Narrative
1 additional sample was alleged to have generated discrepant results on (b)(6) 2025: sample 3: (b)(6) 2025: the initial result was 0.562 mg/dl.The sample was repeated 5 times and generated results of 0.154 mg/dl, 0.154 mg/dl, 0.155 mg/dl, 0.150 mg/dl, and 0.155 mg/dl.The sample was repeated 5 more times and generated results of 0.152 mg/dl, 0.151 mg/dl, 0.150 mg/dl, 0.150 mg/dl, and 0.156 mg/dl.

• 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: 23037889
• Report Number: 1823260-2025-02857
• Device Sequence Number: 13229219
• Product Code: CIG
• UDI-Device Identifier: 07613336121061
• UDI-Public: 07613336121061
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• 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): 12/12/2025

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 Catalogue Number: 08056951190
• Device Lot Number: ASKU
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 11/07/2025; 11/26/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/12/2025
• 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: 63 YR
• Patient Sex: Unknown