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

Catalog Number 03737551190

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

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

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

The alarm trace showed that there was an abnormal magnet movement.Investigation is ongoing.

Event Description

We received an allegation of questionable results for 4 patients' samples tested with elecsys ferritin assay on a cobas e411 module serial number (b)(4).The following results were reported: on (b)(6) 2023: sample 1: 0.7 g/l rerun 54.94 g/l.Sample 2: <0.5 g/l rerun 286.2 g/l.On (b)(6) 2023: sample 3: 0.623 g/l rerun 352.3 g/l and 353.5 g/l.Sample 4: 0.868 g/l rerun 67.28 g/l.On (b)(6) 2023 calibration was performed and the signals were slightly lower than the expected range but they seemed okay.Qc recovery showed that it was close to the target.

Manufacturer Narrative

The field service engineer (fse) conducted a performance check and the instrument was performing within specifications.The fse also did paddle, magnet, and probe adjustments.Calibration was performed on (b)(6) 2023.The signals were slightly lower than the expected range.Qc was acceptable.A general reagent problem can be excluded.The reagent performs with specifications.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: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 16677043
• MDR Text Key: 312642459
• Report Number: 1823260-2023-01092
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 05/26/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 03737551190
• Device Lot Number: 695220
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 04/04/2023
• Supplement Dates Manufacturer Received: 05/02/2023
• Supplement Dates FDA Received: 05/29/2023
• 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
• Patient Sequence Number: 1