MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALB2 ALBUMIN GEN.2; BROMCRESOL GREEN DYE-BINDING, ALBUMIN

Catalog Number	03183688122
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they ran patient samples as part of a lot-to-lot comparison on the cobas 8000 c 502 module when starting a new lot of alb2 albumin gen.2.Two patient samples had discrepant results for albumin.When tested with the old lot (lot 64818101), the first sample initially resulted in an albumin value of 2.60 g/dl and this value was reported outside of the laboratory.The sample was repeated twice with the new lot (lot 657589), resulting in values of 4.37 g/dl and 4.36 g/dl.The repeat values were deemed correct.When tested with the old lot (lot 64818101), the second sample initially resulted in an albumin value of 2.54 g/dl and this value was reported outside of the laboratory.The sample was repeated twice with the new lot (lot 657589), resulting in values of 4.80 g/dl and 4.79 g/dl.The repeat values were deemed correct.The serial number of the c 502 analyzer is (b)(4).
Additional Manufacturer Narrative
The last calibration performed on (b)(6)2022 was ok and there were no alarms.Quality controls recovered within established ranges.There was no indication of a reagent performance issue.The field service engineer determined the sampling mechanism was sticking.The sampling mechanism was replaced.The prove adjustment was verified.Mechanism checks passed.An instrument check and precision studies were performed.Operational and mechanical checks passed.The investigation determined the service actions resolved the issue.

• Brand Name: ALB2 ALBUMIN GEN.2
• Common Device Name: BROMCRESOL GREEN 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: 16096673
• Report Number: 1823260-2023-00041
• Device Sequence Number: 6704345
• Product Code: CIX
• UDI-Device Identifier: 04015630918898
• UDI-Public: 04015630918898
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K033009
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2023

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: 09/30/2023
• Device Catalogue Number: 03183688122
• Device Lot Number: 64818101
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 01/25/2023
• 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 Sex: Unknown