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

Catalog Number 03737551190

Device Problem Non Reproducible Results (4029)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/15/2020

Event Type  malfunction  

Manufacturer Narrative

Upon review of calibration data, the customer's calibration signals were acceptable, although signals are somewhat below the expected signal ranges.Quality controls were acceptable.Upon review of the alarm trace, no relevant alarms occurred on the day of the event.Performance testing was run on the analyzer and this failed.The investigation could not identify a product problem.The cause of the event could not be determined.

Manufacturer Narrative

The reporter deleted the ferritin application from the analyzer, then loaded a new reagent lot number (431645) and ran calibration and controls.This event occurred in (b)(6).

Event Description

The initial reporter stated they received discrepant results for five patient samples tested with elecsys ferritin on a cobas e 411 immunoassay analyzer and a second elecsys system at another site.The values did not compare to those measured on a vidas system.The reporter believe the values from the vidas system and the elecsys analyzer at the second site to be correct.The model of the elecsys analyzer used at the customer site was requested, but not provided.This analyzer is either an e411 analyzer or a cobas 6000 e 601 module.For the first three samples, no incorrect results were reported outside of the laboratory.For the fourth and fifth samples, it was asked, but it is not known if any incorrect values were reported outside of the laboratory.The first sample initially resulted with a ferritin value of 11.96 ng/ml accompanied by a data flag when tested on the customer's e411 analyzer.The sample was repeated on a vidas analyzer, resulting with a value of 1.5 ng/ml.The sample was tested on an unknown elecsys analyzer at a second site on 16-jan-2020, resulting with a ferritin value of 2.7 ng/ml.A value of 1.7 ng\ml was also provided as a measurement obtained on the elecsys analyzer at the second site.It was asked, but it is not known if this is an additional value from the elecsys analyzer or if it replaces the provided value of 2.7 ng/ml.The second sample, from a female patient, initially resulted with a ferritin value of 51.28 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on a vidas analyzer, resulting with a value of 29.83 ng/ml.The third sample, from a female patient, initially resulted with a ferritin value of 61.19 ng/ml when tested on the customer's e411 analyzer.The sample was repeated on a vidas analyzer, resulting with a value of 33.8 ng/ml.The fourth sample, from a female patient, initially resulted with a ferritin value of 3.56 ng/ml when tested on the customer's e411 analyzer.When tested on the elecsys analyzer at the second site, the sample resulted with a value of 1.54 ng/ml.The fifth sample, from a female patient, initially resulted with a ferritin value of 21.46 ng/ml when tested on the customer's e411 analyzer.When tested on the elecsys analyzer at the second site, the sample resulted with a value of 15.6 ng/ml.The serial number of the customer's e411 analyzer is (b)(4).The serial number of the elecsys analyzer used at the second site was requested, but not provided.

Manufacturer Narrative

For sample 1, the correct repeat value from the unknown elecsys analyzer at a second site on (b)(6) 2020 was confirmed as 2.7 ng/ml.The 1.7 ng/ml value is to be disregarded.

• 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: 9720240
• MDR Text Key: 189569471
• Report Number: 1823260-2020-00470
• 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,Followup
• Report Date: 04/21/2020

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: 36646401
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/18/2020
• Supplement Dates Manufacturer Received: 01/24/2020; 01/24/2020
• Supplement Dates FDA Received: 02/20/2020; 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1