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

Catalog Number	08056951190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for two patient samples tested with bil-d gen.2 on a cobas c 503 analytical unit.The first sample initially resulted in a direct bilirubin value of 2.90 mg/dl.The sample was repeated, resulting in the following values: 0.136 mg/dl, 0.124 mgdl, 0.131 mg/dl, 0.135 mg/dl, 0.134 mg/dl, 0.136 mg/dl, 0.135 mg/dl, 0.136 mg/dl, 0.132 mg/dl, 0.134 mg/dl, 0.128 mg/dl.The second sample initially resulted in a direct bilirubin value of 0.944 mg/dl.The sample was repeated, resulting in the following values: 0.152 mg/dl, 0.149 mg/dl, 0.151 mg/dl, 0.142 mg/dl, 0.146 mg/dl.
Additional Manufacturer Narrative
The serial number of the c 503 analyzer is (b)(6).A review of the provided reaction monitor data showed abnormal results for the initial values and showed normal results for the repeat results.Calibration and controls were acceptable.The investigation is ongoing.
Additional Manufacturer Narrative
The investigation determined the issue is consistent with insufficient pre-analytic sample handling.

• 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 21019047
• Report Number: 1823260-2024-03822
• Device Sequence Number: 9156251
• 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
• Report Date (Section B): 01/07/2025

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: 09/30/2025
• Device Catalogue Number: 08056951190
• Device Lot Number: 80469501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/07/2025
• 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