MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM

Catalog Number	08890587190
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	10/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated they received a questionable result for one patient sample tested with elecsys hcg stat on a cobas e411 rack.The patient was tested for pregnancy and is confirmed to be pregnant.The sample resulted in an hcg value of 2.47 miu/ml.A second sample from the patient was collected at another site and tested with the roche elecsys hcg stat reagent on 23-oct-2023, resulting in an hcg value of 52000 miu/ml.
Additional Manufacturer Narrative
The serial number of the e411 analyzer is (b)(6).The investigation is ongoing.
Additional Manufacturer Narrative
Calibration signals were within expectations.Quality controls recovered within assigned ranges on the day of the event.The sample centrifugation speed was higher than recommended by the tube manufacturer.Upon review of the alarm trace, a low sample volume and a clot alarm were observed near the time the complained sample was measured.Maintenance was performed on the instrument.An instrument performance check was performed and was within specifications.The investigation did not identify a product issue.The issue is consistent with incorrect pre-analytic sample handling.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN (HCG) 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: 18265459
• Report Number: 1823260-2023-03834
• Device Sequence Number: 18107656
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K203227
• 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): 12/15/2023

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: 07/31/2024
• Device Catalogue Number: 08890587190
• Device Lot Number: 663476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2023
• Supplement Date Received by Manufacturer: 12/14/2023
• Initial Report FDA Received Date: 12/05/2023
• Supplement Report FDA Received Date: 12/15/2023
• 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 Sex: Unknown