MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BIL-D BILIRUBIN DIRECT; DIAZO COLORIMETRY, BILIRUBIN

Model Number BIL-D G2

Device Problem High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The investigation could not identify a product problem.The cause of the event could not be determined.The follow up/corrective actions were that the customer changed their method from the "jendrassic" "groff" method to the doumas method.The doumas method will provide the customer with the expected ranges that they prefer.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.Erroneous high results were generated by the cobas c 111.The events involved a total of 44 patients with high results for the bil-d bilirubin direct assay.The patients' ages ranged from (b)(6) - (b)(6) years.The other patients' ages were requested, but were not provided.The patients' weights were requested, but were not provided.There were 3 males and 6 females.The other patients' genders were requested, but were not provided.The patients' races were requested, but were not provided.The patients' ethnicities were requested, but were not provided.

• Brand Name: BIL-D BILIRUBIN DIRECT
• Type of Device: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofferstrasse 116; na; mannheim (baden-wurttemberg), na 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 8280716
• MDR Text Key: 134334503
• Report Number: 1823260-2019-90008
• Device Sequence Number: 1
• Product Code: CIG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: BIL-D G2
• Device Lot Number: ASKU
• Type of Device Usage: N
• Patient Sequence Number: 1