MAUDE Adverse Event Report: ROCHE DIAGNOSTICS TINA-QUANT FERRITIN GEN.4; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number	04885317190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was requested for investigation.The investigation is ongoing.
Event or Problem Description
The initial reporter received a questionable ferr4 tina-quant ferritin gen.4 result for one patient sample with the cobas 6000 c 501 module serial number (b)(4).The initial result was 495 ng/ml.The repeated result run in reduced volume was 147 ng/ml.The questionable result was not reported outside of the laboratory.The customer is questioning an interference due to previous results showing the same pattern of an initially high result repeating lower.
Additional Manufacturer Narrative
Medwatch field d4 catalog number has been updated.
Additional Manufacturer Narrative
The sample was received for investigation and tested using a c501 and an e601.The customer¿s results could be reproduced.A difference between the ferritin concentration value generated on c501 in normal mode and the ferritin value generated on e601 could be also seen clearly.The results indicate an interferent in the sample that interferes with the clinical chemistry assay format but has no influence on the elecsys assay result.The patient¿s medications were further investigated for potential interference.None of the tested active compounds of the medications showed interference in the assay.A further, more detailed characterization of the potential interfering compound is not possible with the remaining sample material.The investigation found the issue to be consistent with a sample-specific unknown interferent.A product problem could not be found.

• Brand Name: TINA-QUANT FERRITIN GEN.4
• 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12244520
• Report Number: 1823260-2021-02205
• Device Sequence Number: 14598824
• Product Code: DBF
• UDI-Device Identifier: 04015630922819
• UDI-Public: 04015630922819
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100538
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/16/2021

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: 02/28/2023
• Device Catalogue Number: 04885317190
• Device Lot Number: 538712
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/08/2021
• Supplement Date Received by Manufacturer: 07/08/2021; 10/29/2021
• Initial Report FDA Received Date: 07/29/2021
• Supplement Report FDA Received Date: 08/18/2021; 11/16/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ALLOPURINOL; BI PETERAX = PERINDOPRIL + INDAPAMIDE; LECTIL = BETA HISTINE; LERCANIDIPINE; TANGANIL = ACETYL LEUCINE
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 140 KG