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

Model Number	BIL-T G3
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation did not identify a product problem.The were no follow up/corrective actions for the event.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 events.Erroneous low results were generated by the cobas 8000 c 702 module.The events involved a total of 1 patient with the following: one erroneous result for bilt3 bilirubin total gen.3.The patient's age was requested, but not provided.The patient's weight was requested, but not provided.There patient's gender was requested, but not provided.The patient's race was requested, but not provided.The patient's ethnicity was requested, but not provided.

• 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: 8281240
• Report Number: 1823260-2019-90053
• Device Sequence Number: 159057
• Product Code: CIG
• UDI-Device Identifier: 04015630928903
• UDI-Public: 4015630928903
• 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

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: BIL-T G3
• Device Lot Number: 318161
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/28/2019
• Patient Sequence Number: 1