MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG+B; SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN

Model Number	HCG+BETA
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	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The field service engineer (fse) verified the analyzer fluidics, performed a mechanical check, and verified the probe voltage.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg + beta test system results for 1 patient plasma sample on a cobas e 411 immunoassay analyzer.The initial hcg result was 7.21 miu/ml.The customer questioned the initial result as it was expected to be negative per the patient's clinical status, which prompted them to repeat the sample.The sample was repeated on another analyzer and the result was <0.100 miu/ml with a data flag.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
Calibration and controls were acceptable.A general reagent issue can be ruled out.Isolated non-reproducible results do not represent a general malfunction of the assay.The field service engineer performed instrument checks.Performance testing recovered within specifications.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG+B
• Common Device Name: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• 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: 20788417
• Report Number: 1823260-2024-03456
• Device Sequence Number: 7883253
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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
• Report Date (Section B): 12/23/2024

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 Model Number: HCG+BETA
• Device Catalogue Number: 03271749160
• Device Lot Number: 774930
• 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: 11/05/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/23/2024
• 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: Female