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

Catalog Number 03271749190

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 10/27/2023

Event Type  malfunction  

Event Description

The initial reporter stated they received discrepant results for one patient sample tested with elecsys hcg+beta on a cobas e411 rack.The sample initially resulted in an hcg+b value of 50.71 miu/ml with a data flag.The sample was repeated on (b)(6) 2023, resulting in an hcg+b value of < 0.100 miu/ml with a data flag.

Manufacturer Narrative

The e411 analyzer serial number is (b)(6).The provided control data was acceptable.The investigation is ongoing.Medwatch field e1 address - the full address was provided as (b)(6).

Manufacturer Narrative

The long term quality control recovery was acceptable.Controls were not tested on the day of the event.Isolated non-reproducible results do not represent a general malfunction of the assay.The investigation could not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG+BETA
• 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: 18165960
• MDR Text Key: 329095876
• Report Number: 1823260-2023-03668
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): Y
• Reporter Country Code: TH
• PMA/PMN Number: K003178
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03271749190
• Device Lot Number: 709174
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1