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

Catalog Number	04491785160
Medical Device Problem Code	Unable to Obtain Readings (1516)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Last calibration was performed on (b)(6) and it was accepable with no alarms.The alarm trace contained an abnormal sample probe movement alarm on date of the event.The cobas e601 analyzer was with a serial number of (b)(6).Investigation is ongoing.
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with elecsys ferritin (ferr) assay on a cobas 6000 cobas e601 immunoassay analyzer.Initial result: 0.768 ng/ml repeat result: 18.65 ng/ml the questionable result was reported outside the laboratory.The customer noticed the questionable result while reviewing the testing and therefore, repeated the sample.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
There was an alarm indicating an abnormal sample probe movement.Based on the data provided a clear root cause could not be identified.A general instrument or reagent problem could not be identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS FERRITIN
• Common Device Name: FERRITIN IMMUNOLOGICAL TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• Manufacturer (Section G): ROCHE DIAGNOSTICS GMBH; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; na; indianapolis, IN 46250 ; 3174767531
• MDR Report Key: 17183791
• Report Number: 1823260-2023-02046
• Device Sequence Number: 6494936
• Product Code: JMG
• UDI-Device Identifier: 04015630938957
• UDI-Public: 04015630938957
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K971833
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: 04491785160
• Device Lot Number: 69522603
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female