MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBP ALBUMIN BCP; BROMCRESOL PURPLE DYE-BINDING, ALBUMIN

Model Number	ALB BCP
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Calibration data was ok.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with albp albumin bcp on a cobas 8000 c702 module (serial number (b)(4).No questionable results were reported outside of the laboratory.The sample initially resulted in an albumin value of 82.9 g/l and it repeated as 40.0 g/l.
Additional Manufacturer Narrative
Quality controls were acceptable on the day of the event.The investigation could not identify a product problem.The cause of the event could not be determined.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: ALBP ALBUMIN BCP
• Common Device Name: BROMCRESOL PURPLE DYE-BINDING, ALBUMIN
• 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: 16531768
• Report Number: 1823260-2023-00792
• Device Sequence Number: 7170349
• Product Code: CJW
• UDI-Device Identifier: 04015630928064
• UDI-Public: 04015630928064
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K844426
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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): 04/10/2023

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 Model Number: ALB BCP
• Device Catalogue Number: 05975573190
• Device Lot Number: 65252401
• 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: 02/23/2023
• Supplement Date Received by Manufacturer: 03/21/2023
• Initial Report FDA Received Date: 03/13/2023
• Supplement Report FDA Received Date: 04/10/2023
• 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: 67 YR
• Patient Sex: Male