MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+ BETA; TOTAL HUMAN CHORIONIC GONADOTROPIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY

Catalog Number	09744428190
Medical Device Problem Codes	Mechanical Problem (1384); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
There was an allegation of questionable results for 5 patient samples tested for elecsys hcg+ss (hcg + b) on two cobas e 801 analytical units.(analyzer 1 and analyzer 2) discrepant results for 3 patient samples were provided.Patient 1 initial result from analyzer 2 was 0.2 miu/ml with a data flag.The repeat result was 34.5 miu/ml.Patient 2 initial result from analyzer 2 was 0.200 miu/ml with a data flag.The repeat result was 41.7 miu/ml.On (b)(6) 2025, patient 3 initial result from analyzer 1 was 0.2 miu/ml with a data flag.The repeat result was 72.7 miu/ml.The repeat results were believed to be correct.
Additional Manufacturer Narrative
Analyzer 1 serial number was (b)(6).Analyzer 2 serial number was (b)(6).
Additional Manufacturer Narrative
For both analyzers: the alarm trace contained multiple sample alarms.These can indicate poor sample quality.Calibration and qc were acceptable.The field service engineer (fse) found that the reagent needed to be recalibrated.The fse recalibrated the reagent pack.Calibration, qc, instrument checks, and precision checks were all acceptable.The investigation determined the event was due to the customer not properly calibrating the reagent.A product issue was not found.
Additional Manufacturer Narrative
This event was reported by the customer to fda as mw5183548.Section e4 was updated.Information for 1 patient was provided of female, 32 years, white race.It is not clear to which patient this information belongs.Due to a response on the medwatch report, the customer was contacted by roche for clarification.The customer confirmed that there was no patient harm, as all results were caught by the clinicians.

• Brand Name: ELECSYS HCG+ BETA
• Common Device Name: TOTAL HUMAN CHORIONIC GONADOTROPIN IVD, KIT, CHEMILUMINESCENT IMMUNOASSAY
• 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: natalie catton ; 9115 hague road; indianapolis, IN 46250
• MDR Report Key: 22686375
• Report Number: 1823260-2025-02368
• Device Sequence Number: 9000341
• Product Code: DHA
• UDI-Device Identifier: 07613336217535
• UDI-Public: 07613336217535
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K003178
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2026

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: 09/30/2025
• Device Catalogue Number: 09744428190
• Device Lot Number: 792314
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/04/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 03/05/2026
• Initial Report FDA Received Date: 08/01/2025
• Supplement Report FDA Received Date: 08/21/2025; 03/30/2026
• 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