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

Catalog Number 04469658190

Device Problem High Test Results (2457)

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

Event Date 02/14/2024

Event Type  malfunction  

Manufacturer Narrative

The c501 analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

The initial reporter stated they received discrepant results for two patient urine samples tested with albt2 tina-quant albumin gen.2 on a cobas 6000 c501 module.The first sample initially resulted in a microalbumin value of 6.76 mg/dl and it repeated as 0.35 mg/dl.The field service engineer checked the gear pump pressure, the probe, and probe dispensing.The probes were cleaned and adjustments were checked.The wash station and tubing integrity were also checked.The lamp and cuvettes were replaced.On (b)(6) 2024, the customer encountered the issue again with a second sample.This second sample initially resulted in a microalbumin value of 11.26 mg/dl.The sample was repeated twice, resulting in values of 0.76 mg/dl and 0.13 mg/dl.

Manufacturer Narrative

Quality control data showed imprecision with out of range high results.The field service engineer replaced the sample probe and rinse tubing.The probe was adjusted and the gear pump pressure was checked.The cells and lamps were replaced.The investigation determined the service actions (probe and tubing replacement) resolved the issue.

• 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): HITACHI HIGH TECH CORP.; 882 ichige hitachinaka; ibaraki 312-8 504; JA 312-8504
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250-0457
• MDR Report Key: 18818738
• MDR Text Key: 337427168
• Report Number: 1823260-2024-00628
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: K060373
• 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: 03/13/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04469658190
• Device Lot Number: 758117
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2024
• 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