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

Catalog Number	05950929190
Medical Device Problem Codes	Low Test Results (2458); Low Readings (2460)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter complained of discrepant results for 8 patient samples tested for elecsys he4 assay (he4) on a cobas 8000 e 602 module.The questionable results were from one particular reagent pack.The repeat results were from the same lot number but a different reagent pack.Refer to attached data for the results.The questionable results were reported outside of the laboratory.The e602 module serial number was (b)(4).
Additional Manufacturer Narrative
The initial qc results were outside of the target range; the repeat qc results were within the target range.Microbeads were found agglutinated on the lid of the reagent pack in question.The issue was resolved when the customer changed to a different reagent pack.A general reagent issue can be excluded as the repeat results from a different reagent pack with the same lot number gave expected results.The investigation did not identify a product problem.The investigation determined the event was consistent with a transportation or storage issue affecting one particular reagent pack.
Additional Manufacturer Narrative
The initial qc results were outside of the target range; the repeat qc results were within the target range.Microbeads were found agglutinated on the lid of the reagent pack in question.The issue was resolved when the customer changed to a different reagent pack.A general reagent issue can be excluded as the repeat results from a different reagent pack with the same lot number gave expected results.The investigation did not identify a product problem.The investigation determined the event was consistent with a transportation or storage issue affecting one particular reagent pack.
Event or Problem Description
The initial reporter complained of discrepant results for 8 patient samples tested for elecsys he4 assay (he4) on a cobas 8000 e 602 module.The questionable results were from one particular reagent pack.The repeat results were from the same lot number but a different reagent pack.Refer to attached data for the results.The questionable results were reported outside of the laboratory.The e602 module serial number was (b)(4).

• Brand Name: ELECSYS HE4 ASSAY
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 13284875
• Report Number: 1823260-2022-00140
• Device Sequence Number: 19379907
• Product Code: OIU
• UDI-Device Identifier: 04015630929641
• UDI-Public: 04015630929641
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 01/18/2022

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: 11/30/2022
• Device Catalogue Number: 05950929190
• Device Lot Number: 533180
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2021
• Initial Report FDA Received Date: 01/18/2022
• 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 Sex: Unknown