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

Catalog Number 05950929190

Device Problems Low Test Results (2458); Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2021

Event Type  malfunction  

Event 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).

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.

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 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
• Type of Device: 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
• MDR Text Key: 286244477
• Report Number: 1823260-2022-00140
• Device Sequence Number: 1
• Product Code: OIU
• UDI-Device Identifier: 04015630929641
• UDI-Public: 04015630929641
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K112624
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 05950929190
• Device Lot Number: 533180
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1