MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERR4; FERRITIN

Catalog Number	05172390190
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One sample of the patient was provided for investigation.The investigation tested the patient¿s sample in normal and decreased mode, resulting in ferr4 values of 315.7 ug/l and 285.5 ug/l.The sample was also tested with the elecsys ferritin on a cobas e602, resulting in a ferr value of 131.8 ng/ml.The sample was also tested on a cobas c503 with further assays, resulting in the following results: iga2 = 2.95 g/l, igm2 = 1.10 g/l, igg2 = 10.3 g/l, kapp2 = 2.73 g/l, lamb2 = 1.53 g/l.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received questionable ferr4 (tina-quant ferritin gen.4) results for several samples from one patient, tested on a cobas 8000 c702 module.It was asked but it is unclear if all results were measured from the same sample material or from different drawings.According to the physician and the results of myelography, the results did not fit to the patient¿s clinical picture.On (b)(6) 2022, the patient had a ferr4 value of 224.8 ug/l.On (b)(6) 2022, the patient had a ferr4 value of 235.3 ug/l.On (b)(6) 2022, the patient had a ferr4 value of 221.6 ug/l.On (b)(6) 2022, the patient had a ferritin value of 5 ug/l, tested with a competitor method.This result was deemed correct.On (b)(6) 2022, the patient had a ferr4 value of 207.7 ug/l.The questionable results were reported outside of the laboratory.The ferr4 reagent lot was 63670701 with an expiration date of 30-apr-2023.
Additional Manufacturer Narrative
It was confirmed that the results were obtained from different sample drawings.
Additional Manufacturer Narrative
The sample was further tested non-diluted and by using a 1:20 dilution, resulting in ferr4 values of 314 ug/l and 300 ug/l.The sample was then tested non-diluted and by using a 1:10 dilution on a siemens bn prospec analyzer, resulting in ferr values of 110 ug/l and 122 ug/l.The investigation did not detect an interference by gammopathy.The investigation determined that the sample material shows non-reproducible results when different analytical methods are used.The antibodies used in the test reagents differ in specificity which may account for non-reproducible recoveries on specific samples.The issue is consistent with a rare commutability issue of the biological material.There is no indication for a general product problem.

• Brand Name: FERR4
• Common Device Name: FERRITIN
• 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: 16101356
• Report Number: 1823260-2023-00057
• Device Sequence Number: 6275009
• Product Code: DBF
• UDI-Device Identifier: 04015630925308
• UDI-Public: 04015630925308
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/21/2023

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: 04/30/2024
• Device Catalogue Number: 05172390190
• Device Lot Number: 63670701
• 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: 12/15/2022
• Supplement Date Received by Manufacturer: 01/10/2023; 03/30/2023
• Initial Report FDA Received Date: 01/05/2023
• Supplement Report FDA Received Date: 02/17/2023; 04/21/2023
• 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