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

Catalog Number 07027273190

Device Problems Low Test Results (2458); Non Reproducible Results (4029)

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

Event Date 12/14/2023

Event Type  malfunction  

Event Description

There was an allegation of questionable elecsys ferritin results for 3 patient samples on two cobas e 801 analytical units.For sample 1, the initial ferritin result was 4.93 ng/ml.The sample was repeated the next day and the result was 118 ng/ml.For sample 2, the initial ferritin result was 1.59 ng/ml.The sample was repeated the next day and the result was 30.5 ng/ml.For sample 3, the initial ferritin result was 2.66 ng/ml.The sample was repeated the next day and the result was 56.0 ng/ml.The results for samples 1 and 2 were produced by analyzer serial number (b)(6).The results for sample 3 were produced by analyzer serial number (b)(6).

Manufacturer Narrative

The investigation is ongoing.

Manufacturer Narrative

The field service engineer (fse) performed an instrument check successfully.The investigation did not identify a product problem.The root cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18474015
• MDR Text Key: 332987858
• Report Number: 1823260-2024-00093
• Device Sequence Number: 1
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 07027273190
• Device Lot Number: 73073101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Sex: Male