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 Consequences Or Impact To Patient (2199)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

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 and with ferr4 tina-quant ferritin gen.4 on a cobas 8000 c 702 module at a second site.This medwatch will apply to the elecsys ferritin assay.Please refer to the medwatch with patient identifier (b)(4) for information related to the ferr4 assay.The sample initially resulted with a ferritin value of 313.8 ng/ml when tested with elecsys ferritin on the e 411 analyzer.The 313.8 ng/ml value was reported outside of the laboratory.The sample was repeated again on the e 411 analyzer, resulting with a ferritin value of 298.3 ng/ml on (b)(6) 2019.The sample was repeated on an abbott analyzer, resulting with a ferritin value of 202 ng/ml.The sample was also repeated on a c 702 analyzer at a second site using the ferr4 assay, resulting with a ferritin value of 325.2 (no units provided) on (b)(6) 2019.The serial number of the e 411 analyzer is (b)(4).The serial number of the c 702 analyzer was requested, but not provided.

Manufacturer Narrative

The customer's qc was well within the 3sd range.A general reagent issue could be excluded.All available ferritin results from all methods are above or on the upper end of the respective reference ranges.The investigation could not identify a product problem.Assays from different vendors can generate different values.This relates to the overall setups of the assays, the antibodies used, differences in reference materials/methods, and differences in the standardization methodology used.

• 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: 9629016
• MDR Text Key: 219781667
• Report Number: 1823260-2020-00199
• 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: 03/09/2020

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: 04/30/2020
• Device Catalogue Number: 03737551190
• Device Lot Number: 36646400
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/29/2019
• Initial Date FDA Received: 01/24/2020
• Supplement Dates Manufacturer Received: 12/29/2019
• Supplement Dates FDA Received: 03/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1