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

Catalog Number	08890595190
Medical Device Problem Codes	Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e402 analyzer serial number was (b)(6).
Event or Problem Description
The initial reporter complained of a discrepant high result for 1 patient sample tested for elecsys hcg stat (hcg stat) on a cobas e 402 analytical unit.The initial result was 194 miu/ml.The repeat result was 14 miu/ml.The patient went to another laboratory where the result from an unknown method was 33 miu/ml.
Additional Manufacturer Narrative
Sections a2, a3a, and a4 were updated.Section b3, date of event was updated.The initial report stated: "the initial result was 194 miu/ml.The repeat result was 14 miu/ml.The patient went to another laboratory where the result from an unknown method was 33 miu/ml." additional event details were provided.Clarification of the event should read: on (b)(6) 2025, the initial result from the e402 analyzer was 194 miu/ml.On (b)(6) 2025, the sample was repeated on a vitros analyzer, and the result was 3.48 miu/ml.A 2nd sample was obtained on (b)(6) 2025, and the result from the e402 analyzer was 14.0 miu/ml.The repeat result from the vitros analyzer was 14.96 miu/ml.A 3rd sample was obtained on (b)(6) 2025, and the result from the e402 analyzer was 157 miu/ml.The repeat result from the vitros analyzer was 42.26 miu/ml.
Additional Manufacturer Narrative
Section b7 was updated.The customer believed the vitros results to be correct as they gradually increased.Calibration was acceptable.No qc data was provided for the day of the event.No issues were identified during a review of the alarm trace data.No maintenance issues were identified.The customer used a sample volume of 3 ml; this volume is too low.The sample was centrifuged for 10 minutes at 3000 relative centrifugal force (rcf); this rcf is too high.The different hcg results of both the roche and vitros methods may be due to the patient's condition of a failed in vitro fertilization (ivf) pregnancy.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG STAT
• Common Device Name: HUMAN CHORIONIC GONADOTROPIN TEST
• 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: 21925598
• Report Number: 1823260-2025-01327
• Device Sequence Number: 8728906
• Product Code: DHA
• UDI-Device Identifier: 07613336169223
• UDI-Public: 07613336169223
• Combination Product (Y/N): N
• Initial Reporter Country: PM
• 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,Followup
• Report Date (Section B): 06/10/2025

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: 01/31/2026
• Device Catalogue Number: 08890595190
• Device Lot Number: 821075
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 05/05/2025; 05/30/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 05/28/2025; 06/10/2025
• 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 Age: 36 YR
• Patient Sex: Female
• Patient Weight: 54 KG