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 04/15/2021

Event Type  malfunction  

Manufacturer Narrative

The field service engineer checked probe alignments and pump pressures.The gear pump and wash pump pressures were adjusted.The microalbumin test was calibrated and precision studies were performed; results were within specification.The customer repeated the samples in question and results measured with the new lot of reagent were very close, but these did not match the results obtained with the old lot.The last calibration performed on (b)(6) 2021 with lot 515982 was not ok and had an error.Quality controls were outside of range for reagent lot 515982.The customer confirmed the assay is now working as expected after the service actions and a different reagent lot was installed.The investigation determined the issue was resolved by these actions.Medwatch field udi number (b)(4).

Event Description

The initial reporter stated they started using a new lot number of albt2 tina-quant albumin gen.2 (microalbumin, lot 51598201, expiration date = 31-aug-2022) on the cobas 6000 c (501) module and had multiple failed calibration attempts.Calibration then was successful, but controls were outside of range.The customer pulled patient urine samples that were initially tested using old microalbumin reagent lot 497736 (expiration date unknown) and then tested these using the new lot 51598201.A new shipment of new lot 51598201 was sent to the customer and calibration and controls tested with this reagent passed.The patient urine samples were also tested using this new shipment.There were discrepancies in the results for six patient samples.All initial results measured with the old lot number were reported outside of the laboratory.Refer to the attachment for all patient data.The serial number of the c 501 analyzer is (b)(4).

• 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: 11778556
• MDR Text Key: 250198269
• Report Number: 1823260-2021-01360
• Device Sequence Number: 1
• Product Code: DCF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101203
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Catalogue Number: 04469658190
• Device Lot Number: 51598201, 497736
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2021
• 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: 66 YR
• Patient Weight: 131