BIL-D BILIRUBIN DIRECT BIL-D G2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for BIL-D BILIRUBIN DIRECT BIL-D G2 manufactured by Roche Diagnostics.

Event Text Entries

[134334503] 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.
Patient Sequence No: 1, Text Type: N, H10

[134334504] 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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1823260-2019-90008
• MDR Report Key: 8280716
• Date Received: 2019-01-28
• Date Added to Maude: 2019-01-28
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 0
• Initial Report to FDA: 0
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MICHAEL LESLIE
• Manufacturer Street: 9115 HAGUE ROAD NA
• Manufacturer City: INDIANAPOLIS IN 46250
• Manufacturer Country: US
• Manufacturer Postal: 46250
• Manufacturer Phone: 3175214343
• Manufacturer G1: ROCHE DIAGNOSTICS GMBH
• Manufacturer Street: SANDHOFFERSTRASSE 116 NA
• Manufacturer City: MANNHEIM (BADEN-WURTTEMBERG), NA 68305
• Manufacturer Country: GM
• Manufacturer Postal Code: 68305
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BIL-D BILIRUBIN DIRECT
• Generic Name: DIAZO COLORIMETRY, BILIRUBIN
• Product Code: CIG
• Date Received: 2019-01-28
• Model Number: BIL-D G2
• Lot Number: ASKU
• Device Availability: *
• Device Eval'ed by Mfgr: *
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ROCHE DIAGNOSTICS
• Manufacturer Address: 9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US 46250

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-01-28