MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS FERRITIN; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 04491785190

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The country of origin is (b)(6).The customer performed a heterophilic neutralization procedure on one of the samples and the ferritin result remained high.The patient sample has been requested.The investigation is ongoing.

Event Description

The initial reporter received a questionable elecsys ferritin result from the cobas 6000 e 601 module serial number (b)(4).The result was 586.8 ng/ml.The questionable result was reported outside the laboratory.The same sample was run on an abbott and siemens analyzer.On (b)(6) 2020, the result from the abbott analyzer was 62 ng/ml and on (b)(6) 2020 the result from the siemens analyzer was 114 ng/ml.

Manufacturer Narrative

Two samples from the patient (serum and plasma from the same blood drawing) were sent in for investigation.The patient's sample was investigated and the customer's results were reproduced.A general reagent issue can be excluded.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Type of Device: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 9770202
• MDR Text Key: 213914737
• Report Number: 1823260-2020-00580
• 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: 05/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 04491785190
• Device Lot Number: 39005802
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR