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

Catalog Number 04469658190

Device Problem Low Test Results (2458)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

The field service engineer (fse) cleaned the water tank and water conductivity was acceptable.The fse noted that the sample in question was run in a 13 mm sample tube with no rack adapter.The customer¿s qc data showed very high results.The customer used an x50 dilution for the initial test on the c502 module.Product labeling states: "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:11 dilution.Results from samples diluted using the rerun function are automatically multiplied by a factor of 11." the investigation is ongoing.

Event Description

The initial reporter complained of discrepant results for 1 patient urine sample tested for albt2 tina-quant albumin gen.2 (albt2) on a cobas 8000 c 502 module.The customer first tested the sample manually using a test strip and the result was "positive." the customer then ran the sample on the c502 module using an x50 dilution with a result of 14.0 mg/l.This result was reported outside of the laboratory.The repeat result using an x20 dilution was 1411.6 mg/l.On (b)(6) 2022 the sample was repeated using an x10 dilution and the result was 1410.3 mg/l.The c502 module serial number was (b)(4).

Manufacturer Narrative

The customer used an x50 dilution for the initial test on the c502 module.A 1:50 dilution is not reasonable for the initial test and could have led to the questionable low result.Product labeling states: "determine samples having higher concentrations via the rerun function.Dilution of samples via the rerun function is a 1:11 dilution.Results from samples diluted using the rerun function are automatically multiplied by a factor of 11." in this case, a valid result could have been received by using the decreased mode.The result of 1411.6 mg/l was believed to be correct.The investigation determined the event was consistent with a handling error (dilution factor) at the customer site.

• 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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 15742544
• MDR Text Key: 307594061
• Report Number: 1823260-2022-03508
• Device Sequence Number: 1
• Product Code: DCF
• UDI-Device Identifier: 04015630920587
• UDI-Public: 04015630920587
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: 04469658190
• Device Lot Number: 65268801
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• 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