MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS HCG STAT; HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM

Catalog Number 08890587190

Device Problems High Test Results (2457); Non Reproducible Results (4029)

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

Event Date 12/13/2023

Event Type  malfunction  

Manufacturer Narrative

The analyzer serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of questionable elecsys hcg + beta test system results for 1 patient sample on a cobas e 411 immunoassay analyzer.The doctor questioned the initial result as it did not match the patient's clinical condition, which prompted the customer to repeat the sample.The initial hcg result was 29.11 miu/ml.The repeat result was 22.3 miu/ml.On 15-dec-2023, the sample was repeated 5 times and the results were 21.75 miu/ml, 21.53, miu/ml, 21.92 miu/ml, 21.69 miu/ml, and 22.31 miu/ml.The first repeat result was deemed correct.

Manufacturer Narrative

Section d product information has been updated, as well as g1 manufacturing site and g4.Calibration was last performed on 25-oct-2023.It was found that the customer's qc ranges are set too wide.The root cause of the event was found to be consistent with pre-analytical sample handling issues.No product problem was identified.

• Brand Name: ELECSYS HCG STAT
• Type of Device: HUMAN CHORIONIC GONADOTROPIN (HCG) TEST SYSTEM
• 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: 18464428
• MDR Text Key: 332312429
• Report Number: 1823260-2024-00070
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 07613336169216
• UDI-Public: 07613336169216
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K203227
• 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: 01/29/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 08890587190
• Device Lot Number: 663476
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/08/2024
• Supplement Dates Manufacturer Received: 01/09/2024
• Supplement Dates FDA Received: 01/29/2024
• 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