MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ALBT2 TINA-QUANT ALBUMIN GEN.2; ALBUMIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04469658190
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	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cobas 6000 c 501 serial number was (b)(6).The customer reviewed the recent assay calibrations and found several failures but the calibrations eventually were acceptable.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable albt2 tina-quant albumin gen.2 results from the cobas 6000 c 501 module.The customer received the sample from a sister site for correlation.The customer's initial result did not correlate with the sister site's result.Specific data from the sister site was not provided.The initial result was <1 mg/dl.The repeat result was 21.7 mg/dl.The customer did not know which result was correct and did not provide information about which result was reported outside of the laboratory.
Additional Manufacturer Narrative
The field service engineer determined the reagent pack was the cause of the event.He tested the analyzer and adjusted all fluidics, replaced a valve bank, gear pump, and vacuum rinse nozzle.The customer installed a new lot of the reagent and performed comparisons with no further issues.There was no indication of a performance issue with the reagent as qc results were acceptable.

• Brand Name: ALBT2 TINA-QUANT ALBUMIN GEN.2
• 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: 19953846
• Report Number: 1823260-2024-02327
• Device Sequence Number: 15688841
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (Y/N): Y
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2024

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 Catalogue Number: 04469658190
• Device Lot Number: 770453
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/18/2024
• Supplement Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/11/2024
• 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