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

Catalog Number 03271749160

Device Problems High Test Results (2457); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2023

Event Type  malfunction  

Manufacturer Narrative

The expiration date of hcg+b reagent was not provided.The cobas e411 disk serial number was (b)(6).The field service engineer ran performance testing and the analyzer was performing within specifications.The investigation is ongoing.

Event 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: 446.1 miu/l.1st repeat result: 0 miu/l (from the original sample).2nd repeat result: 0 miu/l (from a new sample).The physician questioned the result.The repeat result was deemed to be correct.

Manufacturer Narrative

The device code (a code) was updated.The last calibration was performed on (b)(6) 2023 and was acceptable with no alarms.Qc recovery is within the range with no indication of a performance issue of the reagent.The field service engineer (fse) found that the sample was compromised.The service actions (troubleshooting) done by the fse resolved the issue.The investigation did not identify a product problem.

• Brand Name: ELECSYS HCG+B
• Type of Device: 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: 17974495
• MDR Text Key: 326142156
• Report Number: 1823260-2023-03368
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03271749160
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 39 YR
• Patient Sex: Female