MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3 BILIRUBIN TOTAL GEN.3; DIAZO COLORIMETRY, BILIRUBIN

Model Number	BILT G3
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation for this event has not been completed.The follow up/corrective actions for this event have not been provided.No devices were returned.This device is not labeled for single use and is not reprocessed or reused.
Event or Problem Description
This report summarizes 1 malfunction event.Non-reproducible results were generated by the cobas c 111.The event involved a total of 2 patients tested for bilt3 bilirubin total gen.3.
Additional Manufacturer Narrative
The investigation could not identify a product problem.The cause of the event could not be determined.There were no follow up actions for this event.

• Brand Name: BILT3 BILIRUBIN TOTAL GEN.3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549733
• Report Number: 1823260-2019-90138
• Device Sequence Number: 19265423
• Product Code: CIG
• UDI-Device Identifier: 04015630928910
• UDI-Public: 04015630928910
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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?: No
• Operator of Device: No Information
• Device Model Number: BILT G3
• Device Lot Number: 36301101
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 07/22/2019
• Patient Sequence Number: 1