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); Output Problem (3005); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serial number of the cobas e411 disk is (b)(6).The investigation is ongoing.
Event or Problem Description
The initial reporter received questionable elecsys hcg stat (hcg stat) results from two patient samples tested on the cobas e 411 analyzer (disk system).The initial results were questioned as the patients were pregnant.Sample 1 the initial result of the undiluted patient sample was <1.00 miu/ml with a data flag.The first repeat result of the undiluted patient sample was >10000 miu/ml with a data flag.The second repeat result with the patient sample at 1:100 dilution was 21828 miu/ml with a data flag.Sample 2 the initial result was <1.00 miu/ml with a data flag.The repeat result was >10000 miu/ml with a data flag.
Additional Manufacturer Narrative
The investigation reviewed the calibration and qc data; the results were within specifications.The alarm trace did not indicate any issues.The clotting time of the patient sample was short at 20 minutes and the centrifugation speed seemed too high at 4000 rpm.The investigation determined the event was due to a preanalytic issue at the customer site (short clotting time and high centrifugation speed).Preanalytics are within the customer's responsibility.A general reagent problem was not present because the qc before the event was within specifications.

• 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: 21067137
• Report Number: 1823260-2025-00017
• Device Sequence Number: 3417712
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 01/29/2025

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: 05/31/2025
• Device Catalogue Number: 08890587190
• Device Lot Number: 768078
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 01/29/2025
• 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: Female