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

Catalog Number 03737551190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 03/16/2021

Event Type  malfunction  

Manufacturer Narrative

The customer noted that calibration signals were low for the reagent pack used for initial testing of the patient samples.The field service engineer replaced the measuring cell.The customer ran calibration and controls.Medwatch field udi number = (b)(4).(b)(6).This event occurred in (b)(6).

Event Description

The initial reporter stated they had issues with recovery for many controls run on the cobas 6000 e 601 module on (b)(6) 2021.It was determined the test counts for the measuring cells were high.The field service engineer adjusted the photomultiplier tube high voltage, ran system volume checks, and ran a blank cell calibration.On (b)(6) 2021, the customer stated they received discrepant results for two patient samples tested with elecsys ferritin on the e 601 analyzer.The reagent pack that was in use was replaced with a standby reagent pack and the samples were repeated, yielding different results.No incorrect results were reported outside of the laboratory.The first sample initially resulted in a ferritin value of 809.1 ng/ml, which repeated as 428.19 ng/ml.The second sample initially resulted in a ferritin value of 87.63 ng/ml, which repeated as 46.53 ng/ml.The serial number of the e 601 analyzer is (b)(4).

Manufacturer Narrative

The reagent pack in use and the standby pack were both calibrated on (b)(6) 2021.The pack that was first in use had calibration signals noticeably lower than expected.The calibration signals from the standby pack were within expectations.Controls run on (b)(6) 2021 were within specified ranges.Upon review of the alarm trace, several abnormal aspiration alarms occurred on the day of the event.This could indicate issues related to sample quality, but likely not related to the event.The investigation determined the issue was consistent with poor calibration on the reagent pack that was first in use.A general instrument issue is unlikely.

• 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
• MDR Report Key: 11635016
• MDR Text Key: 268514708
• Report Number: 1823260-2021-01078
• Device Sequence Number: 1
• Product Code: JMG
• Combination Product (y/n): N
• PMA/PMN Number: K971833
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 03737551190
• Device Lot Number: 49581200
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/20/2021
• Initial Date FDA Received: 04/08/2021
• Supplement Dates Manufacturer Received: 03/20/2021
• Supplement Dates FDA Received: 06/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1