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

Catalog Number	03271749160
Medical Device Problem Codes	High Test Results (2457); Insufficient Device Problem Information (3190); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
We received an allegation about discrepant results for 1 patient's serum sample tested with elecsys hcg+beta (hcg+b) assay on a cobas e411 immunoassay analyzer.Initial result: 225 miu/ml.The physician questioned the result as it did not match the patient's clinical condition (in the first few weeks of pregnancy).The sample was then repeated.Repeat result: 30 miu/ml.The repeat result was deemed to be correct.
Additional Manufacturer Narrative
The hcg+b reagent expiration date was not provided.The cobas e411 disk serial number was (b)(6).Performance testing was done on 25-sep-2023 and 28-nov-2023 and the instrument was performing within specifications.The investigation is ongoing.
Additional Manufacturer Narrative
Calibration and qc were requested but not provided.The customer confirmed that the sample sat for 30 minutes prior to the centrifugation.The alarm trace was requested but not provided.The field service engineer (fse) found no cause for the issue.The fse did a performance check and the instrument was performing within specifications.He did multiple checks including a system volume check, liquid flow cleaning history check, probe position, and wash check and they all passed.The laboratory's humidity was 23% at the time of the service visit.Qc was performed and it was within range.The investigation did 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: 18483180
• Report Number: 1823260-2024-00107
• Device Sequence Number: 2820621
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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): 02/09/2024

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 Catalogue Number: 03271749160
• Device Lot Number: ASKU
• 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: 12/21/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 01/10/2024
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ESTERASE.; PROGESTERONE.
• Patient Sex: Female