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

Catalog Number	03302652190
Medical Device Problem Code	Non Reproducible Results (4029)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The analyzer serial number is (b)(6).The customer stated that their qc recovery data was acceptable.The field service engineer (fse) found that that the reagent pack was the cause of the issue.The customer replaced the reagent pack and recalibrated and ran qc successfully.A precision test was also performed successfully.The service maintenance actions performed by the customer resolved the issue.No further issues were reported after the service visit.
Event or Problem Description
There was an allegation of questionable elecsys hcg + beta test system results for 2 patient serum samples on a cobas 6000 e601 module.The doctor questioned the initial results which prompted the customer to repeat the samples.For sample 1, the initial hcg result was 62.44 miu/ml.The sample was repeated on another e601 analyzer and the result was <0.1 miu/ml.For sample 2, the initial hcg result was 126768 miu/ml.The sample was repeated on another e601 analyzer and the result was 67000 miu/ml.Clarification on if one of the results was accompanied by a data flag was not provided.The repeat results were deemed correct.

• Brand Name: ELECSYS HCG+BETA
• 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 46250-0457
• MDR Report Key: 19583379
• Report Number: 1823260-2024-01830
• Device Sequence Number: 7326860
• Product Code: DHA
• UDI-Device Identifier: 04015630919406
• UDI-Public: 04015630919406
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/21/2024

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: 03302652190
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2024
• Initial Report FDA Received Date: 06/21/2024
• 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