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

Catalog Number	08056692190
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qc was acceptable.No other tests were affected.
Event or Problem Description
The initial reporter complained of discrepant high results for 1 patient tested for alb2 on a cobas pro c 503 analytical unit compared to an unknown type of analyzer in another laboratory."several" samples were obtained from the patient.The results from the c503 unit were always between 25 g/l and 27 g/l.The results from the other laboratory were always between 15 g/l and 17 g/l.The results from the c503 unit were reported outside of the laboratory.The c503 unit serial number was (b)(4).
Additional Manufacturer Narrative
No additional data was provided by the customer.Based on the information provided, the cause of the event could not be determined.
Additional Manufacturer Narrative
Na.

• Brand Name: ALB2
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12555648
• Report Number: 1823260-2021-02859
• Device Sequence Number: 4103014
• Product Code: CIX
• UDI-Device Identifier: 07613336120941
• UDI-Public: 07613336120941
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K033009
• Number of Events Summarized: 1
• Summary Report (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,Followup
• Report Date (Section B): 12/14/2021

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: 07/31/2022
• Device Catalogue Number: 08056692190
• Device Lot Number: 54795801
• 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: 09/09/2021
• Supplement Date Received by Manufacturer: 11/04/2021; 11/25/2021
• Initial Report FDA Received Date: 09/30/2021
• Supplement Report FDA Received Date: 11/24/2021; 12/14/2021
• 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