MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERRITIN CS ELECSYS V2; CALIBRATOR SET FOR FERRITIN IMMUNOLOGICAL TEST SYSTEM

Model Number E411 DISK

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2020

Event Type  malfunction  

Manufacturer Narrative

The customer was not aware of when the calibrator used for calibration was first opened.The customer recalibrated using new calibrator material.Controls and patient samples recovered acceptably.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys ferritin on a cobas e 411 immunoassay analyzer.No incorrect results were reported outside of the laboratory.The sample initially resulted with a ferritin value of < 0.500 ng/ml accompanied by a data flag.The sample was repeated, resulting with a value of < 0.500 ng/ml accompanied by a data flag.The sample was sent to a second laboratory for testing on another e411 analyzer, resulting with a value of 10.46 ng/ml.The ferritin reagent lot number was 49581201, with an expiration date of 31-jan-2022.

Manufacturer Narrative

Two reagent packs of ferritin lot 495812 were calibrated on (b)(6) 2020.The first level calibrator signals recovered much higher than expected.The customer stated they were not aware of when the calibrator used for calibration was first opened.Per product labeling: "the calibrators should only be left on the analyzer during calibration at 20-25 °c.After use, close the bottles as soon as possible and store upright at 2-8 °c.Due to possible evaporation effects, not more than 5 calibration procedures per bottle set should be performed.Calibrator stability after opening at 2-8c: 12 weeks." a new calibration was performed on (b)(6) 2020 was ok and signals were only slightly lower than expected.The investigation determined the issue is consistent with a bad calibration due to inappropriate calibrator handling.The issue was resolved by obtaining a new calibration with fresh calibrator material.

• Brand Name: FERRITIN CS ELECSYS V2
• Type of Device: CALIBRATOR SET FOR FERRITIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11156119
• MDR Text Key: 248358580
• Report Number: 1823260-2021-00121
• 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: 02/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: E411 DISK
• Device Catalogue Number: 4775279001
• Device Lot Number: 388949
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR