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

Catalog Number 07027273190

Device Problem High Test Results (2457)

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

Event Date 06/29/2023

Event Type  malfunction  

Manufacturer Narrative

The serial number of the customer's cobas analyzer is (b)(6).The patient sample was received for investigation.The investigation is ongoing.H3 other text : na.

Event Description

The initial reporter received a questionable elecsys ferritin (ferritin) result from one patient sample tested on an unspecified cobas analyzer.The initial result was not reported outside of the laboratory.The reporter stated that the patient's ferritin result seemed abnormally high prompting them to send the patient to two other laboratories: laboratory 1 which uses an abbott analyzer and laboratory 2 which uses a vitros analyzer.The laboratory methods used are unknown.The initial result from the customer's roche analyzer was 584 ug/ml (reference range: 20-300 ug/ml).The repeat result from laboratory 1's abbott analyzer was 590 ug/ml (reference range: 22 ¿ 275 ug/ml).The repeat result from laboratory 2's vitros analyzer was 377 ug/ml (reference range: 17.9 ¿ 464 ug/ml).This repeat result was deemed correct as it matches the patient's "clinical context".

Manufacturer Narrative

The investigation performed confirmatory measurements, dilution series measurements, and a heterophilic blocking tube (hbt) check using the cobas e 801.The results produced during the investigation do not suggest the presence of an interfering factor.The investigation tested the patient sample on the cobas c 501 using the tina-quant ferritin gen.4 (ferr4) assay.The results reported by the customer were comparable with the investigation results.The investigation confirmed the customer's results.The investigation did not identify a product problem.

• 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: 17389120
• MDR Text Key: 320317889
• Report Number: 1823260-2023-02468
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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
• Report Date: 08/30/2023

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 Catalogue Number: 07027273190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2023
• Initial Date FDA Received: 07/25/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 08/30/2023
• 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