MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04491785190

Device Problem High Test Results (2457)

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

Event Date 02/16/2023

Event Type  malfunction  

Manufacturer Narrative

The customer used an expired dilution reagent for the first repeat result of the sample.Product labeling states "diluent universal 2 stability: unopened at 2-8 °c up to the stated expiration date.Stability: on the analyzers at t 20-25 °c 12 weeks." a new patient sample from (b)(6) 2023 is available and was requested for investigation.The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys ferritin result for one patient sample tested on the cobas 6000 e601 module serial number (b)(4).The initial result was reported outside of the laboratory.The reporter would like to understand the difference in ferritin results between the roche module's electrochemiluminescence immunoassay (eclia) method and an unspecified module's chemiluminescent immunoassay (clia) method used in the partner laboratory.The initial result from the module was 2000 ng/ml with a data flag.The first repeat result from the module with the patient sample at 1/100 dilution factor was 166119 ng/ml with a data flag.The second repeat result from the other module with the patient sample at a dilution factor of 1/5 factor was 8.250 ng/ml.

Manufacturer Narrative

The patient sample was received for investigation.The results reported by the customer were comparable with the results obtained by the investigation.The clinical chemistry method for ferritin also detected a high ferritin value.No heterophilic antibodies seem to be present in this patient sample, as the results after the heterophilic blocking tube (hbt) treatment did not decrease.A general reagent issue can be excluded.The investigation is ongoing.

Manufacturer Narrative

The customer's last calibration performed on (b)(6) 2023 was acceptable.The customer's quality control results were within specifications.The provided patient sample was also tested by using a 1:50 dilution.Both methods, the elecsys as well as the clinical chemistry method for ferritin show values far above the measuring range and comparable to the results reported by the customer.The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used and, differences in reference materials/methods and the standardization methodology used.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN 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: 16622718
• MDR Text Key: 312302412
• Report Number: 1823260-2023-00991
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K971833
• 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,Followup
• Report Date: 06/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 04491785190
• Device Lot Number: 60072101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/27/2023
• Supplement Dates Manufacturer Received: 05/09/2023; 06/01/2023
• Supplement Dates FDA Received: 06/02/2023; 06/29/2023
• 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 Sex: Male