MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), FERRITIN

Catalog Number 03737551190

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2021

Event Type  malfunction  

Manufacturer Narrative

Na.

Event Description

The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys ferritin (ferritin) on a cobas 6000 e 601 module compared to an unknown competitor method in another laboratory.The date of event is an approximation; the customer stated the event occurred "a month ago." the result from the e601 module was 540 ug/l.This result was reported outside of the laboratory.The result from the unspecified competitor method was 360 ug/l.The e601 module serial number was (b)(4).

Manufacturer Narrative

The customer did not provide any additional information.Based on the information provided, the investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Type of Device: RADIOIMMUNOASSAY (TWO-SITE SOLID PHASE), 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: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 12758625
• MDR Text Key: 280527671
• Report Number: 1823260-2021-03239
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K971833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03737551190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1