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

Catalog Number	07027273190
Medical Device Problem Codes	Low Test Results (2458); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable elecsys ferritin results for 3 patient samples on two cobas e 801 analytical units.For sample 1, the initial ferritin result was 4.93 ng/ml.The sample was repeated the next day and the result was 118 ng/ml.For sample 2, the initial ferritin result was 1.59 ng/ml.The sample was repeated the next day and the result was 30.5 ng/ml.For sample 3, the initial ferritin result was 2.66 ng/ml.The sample was repeated the next day and the result was 56.0 ng/ml.The results for samples 1 and 2 were produced by analyzer serial number (b)(6).The results for sample 3 were produced by analyzer serial number (b)(6).
Additional Manufacturer Narrative
The investigation is ongoing.
Additional Manufacturer Narrative
The field service engineer (fse) performed an instrument check successfully.The investigation did not identify a product problem.The root 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; sandhofer strasse 116; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: amy nelson ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 18474015
• Report Number: 1823260-2024-00093
• Device Sequence Number: 20435027
• Product Code: JMG
• UDI-Device Identifier: 04015630939688
• UDI-Public: 04015630939688
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• 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: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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: 09/30/2024
• Device Catalogue Number: 07027273190
• Device Lot Number: 73073101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/15/2023
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 36 YR
• Patient Sex: Male