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); Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The calibration and qc recovery data provided was acceptable.The field service engineer (fse) changed the reagent, changed the pinch tubing, performed fine tuned alignment to probes, adjusted the sipper nozzle, and performed mechanical checks, calibration, and qc successfully.The investigation is ongoing.
Event or Problem Description
There was an allegation of questionable elecsys hcg + beta test system results for 2 patient serum samples on a cobas e 411 immunoassay analyzer.The customer questioned the initial high results which prompted them to repeat the samples.On 03-jun-2024, sample 1 had an initial hcg result of 9.05 miu/ml.The sample was repeated twice and the results were 0.585 miu/ml and <0.100 miu/ml.The repeat result of <0.100 miu/ml was deemed correct.On 04-jun-2024, sample 2 had an initial hcg result of 44.79 miu/ml with flag.The repeat result was <0.100 miu/ml.The repeat result was deemed correct.No questionable results were reported outside of the laboratory.
Additional Manufacturer Narrative
The alarm trace did not contain a conspicuous event.The service maintenance actions performed by the fse resolved the issue.No further issues were reported after the service visit.

• 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: 19627249
• Report Number: 1823260-2024-01871
• Device Sequence Number: 8610575
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• 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): 08/05/2024

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 Catalogue Number: 03271749160
• Device Lot Number: 709174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 07/16/2024
• Initial Report FDA Received Date: 06/27/2024
• Supplement Report FDA Received Date: 08/05/2024
• 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 Sex: Unknown