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

Catalog Number	08890587190
Medical Device Problem Codes	High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg + beta test system results for 1 patient sample on a cobas e 411 immunoassay analyzer.The doctor questioned the initial result as it did not match the patient's clinical condition, which prompted the customer to repeat the sample.The initial hcg result was 29.11 miu/ml.The repeat result was 22.3 miu/ml.On 15-dec-2023, the sample was repeated 5 times and the results were 21.75 miu/ml, 21.53, miu/ml, 21.92 miu/ml, 21.69 miu/ml, and 22.31 miu/ml.The first repeat result was deemed correct.
Additional Manufacturer Narrative
Section d product information has been updated, as well as g1 manufacturing site and g4.Calibration was last performed on 25-oct-2023.It was found that the customer's qc ranges are set too wide.The root cause of the event was found to be consistent with pre-analytical sample handling issues.No product problem was identified.

• 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 46250-0457
• MDR Report Key: 18464428
• Report Number: 1823260-2024-00070
• Device Sequence Number: 3115085
• 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): 01/29/2024

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 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: 12/13/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 01/29/2024
• 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