MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HE4; EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST

Catalog Number	05950929190
Medical Device Problem Codes	High Test Results (2457); Audible Prompt/Feedback Problem (4020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer¿s e601 module serial number was (b)(6).The serial number for the e601 module at the other hospital was not provided.The competitor method was abbott.Sample material from the patient was requested for investigation.
Event or Problem Description
The initial reporter questioned high results not corresponding to the patient¿s clinical picture when tested for elecsys he4 (he4) on two cobas e 601 modules.The initial result from the customer's e601 module was 248 pmol/l.The patient was tested for he4 on an e601 module at a different hospital and the result was 228.1 pmol/l.The patient was tested by a competitor method at a different hospital and the he4 result was 34.3 pmol/l.
Additional Manufacturer Narrative
The sample was submitted for investigation.The customer's he4 results were reproduced on an e601 module (278 pmol/l).Dilution and spiking experiments were performed and the sample underwent heterophilic blocking tube (hbt) treatment; the results received did not indicate the presence of an interfering substance.The sample underwent polyethylene glycol (peg) treatment; the results suggest the presence of an interfering substance, however, the results generated do not explain the difference in results between the roche method and the abbott method.Further clarification of the root cause for the differences between the roche and abbott results is not possible with available methods and the current state of the art.Product labeling states: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design." the investigation did not identify a product problem.The reagent performs within specification.A general reagent issue can be excluded.

• Brand Name: ELECSYS HE4
• Common Device Name: EPITHELIAL OVARIAN TUMOR ASSOCIATED ANTIGEN (HE4) TEST
• 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: 18367603
• Report Number: 1823260-2023-04145
• Device Sequence Number: 7743103
• Product Code: OIU
• UDI-Device Identifier: 04015630929641
• UDI-Public: 04015630929641
• Combination Product (Y/N): Y
• Initial Reporter Country: CH
• PMA/510(K) Number: K112624
• 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): 02/28/2024

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 Catalogue Number: 05950929190
• Device Lot Number: ASKU
• 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: 12/06/2023
• Supplement Date Received by Manufacturer: 02/27/2024
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 02/28/2024
• 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: 53 YR
• Patient Sex: Female
• Patient Race: Asian