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

Model Number BILT G3

Device Problem Non Reproducible Results (4029)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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 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.

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
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• MDR Report Key: 8549733
• MDR Text Key: 143411613
• Report Number: 1823260-2019-90138
• Device Sequence Number: 1
• Product Code: CIG
• UDI-Device Identifier: 04015630928910
• UDI-Public: 04015630928910
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BILT G3
• Device Lot Number: 36301101
• Patient Sequence Number: 1