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

Catalog Number	08890587190
Medical Device Problem Codes	Unable to Obtain Readings (1516); Incorrect, Inadequate or Imprecise Result or Readings (1535); 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	10/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 analyzer serial number was (b)(6).The field service engineer cleaned a wash station probe line and a sample probe line.Precision studies were acceptable.The investigation is ongoing.
Event or Problem Description
The initial reporter stated they received discrepant results for one patient sample tested with elecsys hcg stat on a cobas 6000 e 601 module.The sample initially resulted in an hcg value of 3 miu/ml.A nurse requested a repeat of the sample because the patient had a positive home pregnancy test.The sample was repeated twice, resulting in hcg values of 119.8 miu/ml and 116.0 miu/ml.The 119.8 miu/ml value was deemed correct.
Additional Manufacturer Narrative
Calibration signals were slightly lower than expected, but were consistent with the previous customer data.Quality controls were acceptable prior to sample measurement.A general reagent issue can be ruled out.Isolated non-reproducible results do not represent a general malfunction of the assay.Upon review of the alarm trace, multiple sample short and system reagent short alarms were observed.The investigation could not identify a product problem.The cause of the event could not be determined.Medwatch field d4 has been updated.

• 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: 20567456
• Report Number: 1823260-2024-03129
• Device Sequence Number: 7391894
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2024

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: 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: 10/10/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 10/30/2024
• Supplement Report FDA Received Date: 11/08/2024
• 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 Age: 37 YR
• Patient Sex: Female