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

Catalog Number	07027273190
Medical Device Problem Code	Low Test Results (2458)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received questionable results for one patient sample tested with the elecsys ferritin assay on a cobas e 801 analytical unit, serial number (b)(4).The results measured on the e 801 analyzer did not agree with other parameters for the patient and did not compare to the result obtained with a competitor method.On (b)(6) 2022 a sample was measured on the cobas e 801 analyzer, resulting in a ferritin value of <0.500 g/l, accompanied by a data flag.The sample was repeated seven times, every time resulting in a value of <0.500 g/l, accompanied by a data flag.On (b)(6) 2022 a sample was measured on the cobas e 801 analyzer, resulting in a ferritin value of <0.500 g/l, accompanied by a data flag.It was asked but it is unknown if the samples from (b)(6) 2022 derive from the same or different blood drawings of the patient.A sample was repeated on a competitor analyzer, resulting in a ferritin value of 11 g/l.It was asked but it is unknown which sample was remeasured on the competitor analyzer.It was asked but it is unknown whether a questionable result was reported outside of the laboratory.
Additional Manufacturer Narrative
Na.
Additional Manufacturer Narrative
It was confirmed that the samples from 01-nov-2022 and 15-nov-2022 derive from different blood drawings of the patient.Medwatch fields a3 and b7 have been updated.
Additional Manufacturer Narrative
A sample of the patient was provided for investigation.The elecsys ferritin result of the customer could be reproduced.No interfering factor against the streptavidin component of the assay could be determined in the sample.The investigation is ongoing.
Additional Manufacturer Narrative
Further investigation of the sample with a heterophilic blocking tube (hbt) did not show a change in results after treatment.There is no indication of the presence of heterophilic antibodies in the patient sample.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and quality controls were acceptable.There is no indication of a general reagent issue.The sample was tested for additional interferences (biotin, ruthenium, bead treatment), but no interference factor could be identified.The investigation could not identify a product problem.The cause of the event could not be determined.Per product labeling: "for diagnostic purposes, the results should always be assessed in conjunction with the patient¿s medical history, clinical examination and other findings.".

• Brand Name: ELECSYS FERRITIN
• Common Device Name: 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: 15958083
• Report Number: 1823260-2022-03962
• Device Sequence Number: 4912971
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K971833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 06/05/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: 07027273190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/07/2022; 01/11/2023; 04/05/2023; 05/09/2023
• Initial Report FDA Received Date: 12/12/2022
• Supplement Report FDA Received Date: 01/03/2023; 02/06/2023; 04/25/2023; 06/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female