MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERR4; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04885317190
Medical Device Problem Codes	Low Test Results (2458); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the customer's cobas 8000 cobas c 502 module is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable ferr4 tina-quant ferritin gen.4 (ferr4) result from one patient sample tested on the cobas 8000 cobas c 502 module.The initial result was reported outside of the laboratory.The patient sample was rerun because of the technologist's observation.The initial result from the module was 0.0 ug/l with a data flag.This result was reported as 8 ug/l with a data flag.The first repeat result from the module with the patient sample autodiluted was 675.5 ug/l.The second repeat result from another analyzer was 663 ug/l.The repeat result was deemed correct. .
Additional Manufacturer Narrative
The investigation reviewed the last calibration performed on (b)(6) 2023; the results were within specifications.The investigation reviewed the qc recovery.The customer's qc recovery was provided for the day of the event, but there were no timestamps provided with the qc.Qc levels 1 - 3 were high out of range (2 standard deviations sd).Two of the measurements were within the provided 2 sd range.For the level 2 qc, all of the four provided measurements were high and out of range (2sd).The field service engineer inspected the module and did not find any cause for the issue adding that it was possibly due to poor sample quality.He then checked the flow path and rinse levels.The customer also replaced the sample probe.The customer performed calibration and qc with successful results.After service, no further issues were reported by the customer.Based on the provided information, the cause of the event could not be determined. .

• Brand Name: FERR4
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 17875358
• Report Number: 1823260-2023-03189
• Device Sequence Number: 7182810
• Product Code: DBF
• UDI-Device Identifier: 04015630922819
• UDI-Public: 04015630922819
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K100538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2023

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 Expiration Date: 10/31/2024
• Device Catalogue Number: 04885317190
• Device Lot Number: 67677701
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/10/2023
• Initial Report FDA Received Date: 10/05/2023
• Supplement Report FDA Received Date: 11/03/2023
• 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 Age: 74 YR
• Patient Sex: Male