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	04/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The e601 module serial number was (b)(6).The field service engineer (fse) decontaminated the sample probe, reagent probe, and sippers.The syringes, liquid level detection (lld) of the sample probe, and adjustments of the sample, reagent, and mixer probes were checked.The investigation is ongoing.
Event or Problem Description
The initial reporter complained of discrepant results for 2 patient samples tested for elecsys hcg stat (hcg stat) on a cobas e 601 module.On (b)(6) 2024 "patient 2" initial result was 97 miu/ml.On (b)(6) 2024 the repeat result was "undetectable." the specific result was not provided.A 2nd sample was obtained.The 2nd sample was run on an e801 module with a result of 1.0 miu/ml.On (b)(6) 2024 "patient 1" initial result was 5 miu/ml.The repeat result was "undetectable." the specific result was not provided.On (b)(6) 2024 another sample tube was repeated and the result was "undetectable." the specific result was not provided.
Additional Manufacturer Narrative
Calibration and qc were acceptable.A review of the alarm trace data showed some messages related to sample quality.No issues were identified during a review of the preanalytical information.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 (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: 19460654
• Report Number: 1823260-2024-01664
• Device Sequence Number: 20536167
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (Y/N): Y
• Initial Reporter Country: BR
• 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): 07/05/2024

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): Follow-Up
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 06/04/2024
• Supplement Report FDA Received Date: 07/05/2024
• 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: 45 YR
• Patient Sex: Female