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

Catalog Number	07027273190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem 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".
Additional 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
• 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: 17389120
• Report Number: 1823260-2023-02468
• Device Sequence Number: 12527969
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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
• Report Date (Section B): 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
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 07/25/2023
• Supplement Report FDA Received Date: 08/30/2023
• 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: Unknown