MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	08056722190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) replaced the sample probe, checked the cell wash station, cleaned the flow path, readjusted a probe, and verified rinsing volumes for the measuring cells.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable albt2 albumin gen.2 results for 2 patient samples on a cobas pro c 503 analytical unit.The customer was prompted to repeat the samples as the results were not consistent with the patients' clinical pictures.On (b)(6) 2023, sample 1 had an initial result of 3.77 g/l.The repeat result was 39.9 g/l.On (b)(6) 2023, sample 2 had an initial result of <3 g/l with flag.The sample was repeated twice and the results were 20 g/l and 20 g/l.No erroneous results were reported outside of the laboratory.
Additional Manufacturer Narrative
The medical coding in this case has been updated.

• Brand Name: ALBT2
• Common Device Name: ALBUMIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17870013
• Report Number: 1823260-2023-03181
• Device Sequence Number: 7490100
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K101203
• 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): 10/19/2023

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: 12/31/2024
• Device Catalogue Number: 08056722190
• Device Lot Number: 71222401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/08/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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