MAUDE Adverse Event Report: ROCHE DIAGNOSTICS FERRITIN ELECSYS E2G; FERRITIN IMMUNOLOGICAL TEST SYSTEM

Catalog Number 07027273190

Device Problems High Test Results (2457); Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Event Description

The initial reporter questioned high results not corresponding to the clinical picture for 3 neonate samples tested for elecsys ferritin (ferritin) on a cobas e801 module.The reporter provided an example for 1 patient sample: the result was 565 ng/ml.This result was reported outside of the laboratory where it was questioned by the physician.The sample has been disposed of and was not repeated.The e801 module serial number was (b)(4).

Manufacturer Narrative

Calibration, qc and precision test results were acceptable.No issues were identified during a review of the alarm trace data.The customer declined a service visit and did not provide any further information.The investigation did not identify a product problem.Based on the data provided, the cause of the event could not be determined.

• Brand Name: FERRITIN ELECSYS E2G
• Type of Device: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11208432
• MDR Text Key: 256386961
• Report Number: 1823260-2021-00227
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 07027273190
• Device Lot Number: 46203301
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 26 DA