MAUDE Adverse Event Report: ROCHE DIAGNOSTICS BILT3; DIAZO COLORIMETRY, BILIRUBIN

Catalog Number	05795397190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received discrepant results for one neonate patient sample tested with the bilt3 (bilirubin total gen.3) assay on a cobas 6000 c501 module, serial number (b)(6).The sample initially resulted in a bilt3 value of 9.5 umol/l and repeated as 237.4 umol/l.The questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
H3 other text : na.
Additional Manufacturer Narrative
The field service engineer (fse) found an issue with the sample probe and replaced it.The degasser was also replaced.Several "aspiration alarms" were observed on the alarm trace data.The investigation determined the event was consistent with a pre-analytical handling issue.

• Brand Name: BILT3
• Common Device Name: DIAZO COLORIMETRY, BILIRUBIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16932101
• Report Number: 1823260-2023-01631
• Device Sequence Number: 15184703
• Product Code: CIG
• UDI-Device Identifier: 04015630928897
• UDI-Public: 04015630928897
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K131544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 05795397190
• Device Lot Number: 66080901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 05/17/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 DA
• Patient Sex: Male