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 09/25/2018

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).

Event Description

The customer questioned results for 1 neonatal patient tested for elecsys ferritin (ferritin) on a cobas 8000 e 602 module.Thirty minutes after being born on (b)(6) 2018, the patient presented with neurological degradation with hypotonia, severe hypoglycemia and hepatocellular insufficiency.At 12:25 a.M.On (b)(6) 2018 the patient was tested for ferritin and the result was 57,907 ug/l suggesting hyperferritinemia.The evening of (b)(6) 2018 biotin treatment was started based on a potential metabolic disease.On (b)(6) 2018 at 5:30 a.M.A new sample was obtained and the ferritin result had decreased to 90 ng/l.The rest of the test results were consistent with the results from (b)(6) 2018.The customer suspects an interference with biotin affecting the ferritin results.There was no allegation that an adverse event occurred.The e602 module serial number was (b)(4).

Manufacturer Narrative

Multiple requests were made for additional information.No further information was provided.The customer did not want to send in the patient sample.Since no sample was submitted, the investigation could not be completed.Product labeling states "the assay is unaffected by biotin levels < 250 nmol/l or < 50 ng/ml.Samples should not be taken from patients receiving therapy with high biotin doses (i.E.> 5 mg/day) until at least 8 hours following the last biotin administration." the investigation did not identify a product problem.The cause of the event could not be determined.

• 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: 8129707
• MDR Text Key: 129518430
• Report Number: 1823260-2018-04621
• 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: 12/19/2018

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 Catalogue Number: 03737551190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/13/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 DA