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

Catalog Number 04469658190

Device Problems Incorrect Measurement (1383); Low Test Results (2458)

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

Event Date 04/22/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with albt2 tina-quant albumin gen.2 on two cobas 6000 c (501) module analyzers.No incorrect results were reported outside of the laboratory.The sample was processed on a modular pre-analytics system and an aliquot of the sample was tested on c 501 serial number (b)(4), resulting in a microalbumin value of 188.1 mg/l.The sample was repeated on c 501 analyzer serial number (b)(4), resulting in a microalbumin value of 138.8 mg/l accompanied by a data flag (>proz) indicating the measurement was outside of the prozone limit programmed for the application.The sample was automatically repeated by the same analyzer using a decreased sample volume, resulting in a value of 6421.4mg/l accompanied by a data flag.The sample was manually diluted 1:2 and 1:5 and repeated on each analyzer.On c 501 serial number (b)(4), the 1:2 diluted sample initially resulted in a microalbumin value of 610.7 mg/l accompanied by a data flag.The sample was repeated on the same analyzer at a decreased sample volume, resulting in a raw value of 3860.0 mg/l, which calculates to a final value of 7720 mg/l when accounting for the dilution factor.On c 501 serial number (b)(4), the 1:5 diluted sample initially resulted in a microalbumin value of 786.9 mg/l accompanied by a data flag.The sample was repeated on the same analyzer at a decreased sample volume, resulting in a raw value of 1449.2 mg/l, which calculates to a final value of 7246 mg/l when accounting for the dilution factor.On c 501 serial number (b)(4), the 1:2 diluted sample initially resulted in a microalbumin value of 482.6 mg/l accompanied by a >proz data flag.The sample was repeated on the same analyzer at a decreased sample volume, resulting in a raw value of 3812.9 mg/l, which calculates to a final value of 7625.8 mg/l when accounting for the dilution factor.On c 501 serial number (b)(4), the 1:5 diluted sample initially resulted in a microalbumin value of 727.3 mg/l accompanied by a data flag.The sample was repeated on the same analyzer at a decreased sample volume, resulting in a raw value of 1513.6 mg/l, which calculates to a final value of 7568 mg/l when accounting for the dilution factor.

Manufacturer Narrative

The field service engineer performed preventive maintenance on the analyzer.The rinse head tubing was replaced and the gear pump pressure was adjusted.The reagent and sample probe alignments were checked.Precision studies were performed and were not within specifications.The investigation could not identify a product problem.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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14406690
• MDR Text Key: 300241718
• Report Number: 1823260-2022-01399
• Device Sequence Number: 1
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 04469658190
• Device Lot Number: 583232
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2022
• 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