MAUDE Adverse Event Report: ROCHE DIAGNOSTICS COBAS C 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	10/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c503 analyzer serial number was (b)(6).During a review of the reaction monitor for the repeat result, a normal reaction was observed.Calibration and qc were acceptable.During a review of the alarm trace data, sample short and abnormal aspiration alarms were observed.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 1 neonate patient sample tested for cobas c bilirubin total gen.3 (bilt3) on a cobas c 503 analytical unit.The initial result was 240 umol/l.This result was reported outside of the laboratory where the physician requested repeat testing and a new sample.The original sample was repeated with a result of 130 umol/l.The result from the 2nd sample was 122 umol/l which is clinically correct.
Additional Manufacturer Narrative
The photometer check and cell blank data were acceptable.Based on the number of "sample short" and "abnormal aspiration" alarms on the alarm trace data, the investigation determined the event was consistent with a pre-analytical handling issue.

• Brand Name: COBAS C 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: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 20636962
• Report Number: 1823260-2024-03226
• Device Sequence Number: 7422409
• Product Code: CIG
• UDI-Device Identifier: 07613336121078
• UDI-Public: 07613336121078
• Combination Product (Y/N): N
• Initial Reporter Country: MU
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2024

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: 02/28/2025
• Device Catalogue Number: 08056960190
• Device Lot Number: 743027
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 12/18/2024
• Initial Report FDA Received Date: 11/08/2024
• Supplement Report FDA Received Date: 12/26/2024
• 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