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

Catalog Number	08056692190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's calibration and qc results were ok.There was no indication of a reagent issue.The investigation determined the root cause is consistent with a sample related issue.No product problem was found.
Event or Problem Description
The initial reporter received a questionable alb2 albumin gen.2 result for one patient sample with a cobas pro c 503 analytical unit serial number (b)(4).The initial result was <0.35 g/l.The repeated result was 8.5 g/l.On (b)(6) 2022, the sample was sent to another laboratory and tested on an unknown roche device where the alb2 result could not be determined.On (b)(6) 2022, the sample was tested with an electrophoresis method with a result of 32.3 g/l.The questionable result was reported outside of the laboratory.

• 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: 13759227
• Report Number: 1823260-2022-00680
• Device Sequence Number: 14903195
• Product Code: CIX
• UDI-Device Identifier: 07613336120941
• UDI-Public: 07613336120941
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/14/2022

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: 12/31/2022
• Device Catalogue Number: 08056692190
• Device Lot Number: 58500201
• 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: 02/17/2022
• Initial Report FDA Received Date: 03/14/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ARONIA + IMMUN; BIACANORM; CALCIUMACETAT NEFRO; CARBAMAZEPINE; ELUTIT CALCIUM; FALITHROM; HYLO VISION HD; LACTULOSE; MIRTAZAPINE; MOVICOL BEUTEL; NOVAMINSULFON; OSTEOTRIOL; PANTOPRAZOLE; SEVELAMER CARBONATE
• Patient Age: 71 YR
• Patient Sex: Male