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

Catalog Number 08056722190

Device Problem Low Test Results (2458)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

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 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.

Manufacturer Narrative

The medical coding in this case has been updated.

• Brand Name: ALBT2
• Type of Device: 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
• MDR Text Key: 324913178
• Report Number: 1823260-2023-03181
• Device Sequence Number: 1
• Product Code: DCF
• UDI-Device Identifier: 07613336120965
• UDI-Public: 07613336120965
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K101203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 08056722190
• Device Lot Number: 71222401
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1