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

Catalog Number 05167043190

Device Problem High Test Results (2457)

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

Event Date 12/25/2023

Event Type  malfunction  

Manufacturer Narrative

The albt2 reagent expiration date was not provided.The c702 module serial number was (b)(6).The customer stated that qc was performed on the day of the event and it was acceptable.The alarm traces showed multiple abnormal aspiration alarms for both sample probes.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's urine sample tested with alb-t tq gen.2 (albt2) assay on cobas 8000 c702 module when compared to a qualitative competitor's method (dry chemical analysis).Initial result: 2941.6 mg/l.Repeat result: negative.The specific value was not provided.On (b)(6) 2024 a new sample was tested and obtained albt2 result of 2.3 mg/l (interpreted as negative).

Manufacturer Narrative

The investigation did not identify a product problem.The albt2 reagent meets the specifications.The cause of the event could not be determined.

• Brand Name: ALBT2 TINA-QUANT ALBUMIN GEN.2
• 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: 18731628
• MDR Text Key: 336626388
• Report Number: 1823260-2024-00477
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): Y
• Reporter Country Code: CH
• 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: 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 05167043190
• Device Lot Number: 712225
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Sex: Male