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

Catalog Number 04885317190

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/18/2017

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).(b)(4).

Event Description

The customer is questioning results for 1 patient tested for ferr4 tina-quant ferritin gen.4 (ferr4) on a cobas 6000 c (501) module.The patient had ferr4 results "higher than 8000 ng/ml." the patient was treated with desferrioxamin but the treatment did not appear successful since ferr4 results remained high.The patient¿s ferr4 was checked 9 times between (b)(6) 2017 and the results remained between 16,000 ng/ml and 36,000 ng/ml.Refer to attached data for the specific results.No adverse event was reported to have occurred.The c501 module serial number (b)(4).The customer is wondering if the ferr4 assay also recovers ferritin complexed with desferrioxamin.The investigation is ongoing.

Manufacturer Narrative

A specific root cause was not identified.Investigations determined that desferrioxamin medication does not interfere with the ferr4 assay.

Manufacturer Narrative

The investigation performed an interference study with desferrioxamin and ferr4.No interference was observed up to a concentration of 1440 mg/l of desferrioxamin.

• Brand Name: TINA-QUANT FERRITIN GEN.4
• Type of Device: 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: 6534052
• MDR Text Key: 74164068
• Report Number: 1823260-2017-00927
• Device Sequence Number: 1
• Product Code: DBF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04885317190
• Device Lot Number: 144229
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1