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

Catalog Number 03271749160

Device Problem High Test Results (2457)

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

Event Date 12/15/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 analyzer's serial number is (b)(6).The investigation is ongoing.

Event Description

There was an allegation of false positive elecsys hcg+b results for 1 patient sample on a cobas e411 module.The positive result was questioned due to it being impossible for the patient to be pregnant.The customer performed additional sample collections and still received positive results on the roche e411.Numeric result values were not provided.The customer tried processing the sample in a hydrophilic tube to remove anything that may cause a positive result, but the result was still positive.

Manufacturer Narrative

The last calibration data that was provided was from (b)(6) 2023 and the results were slightly lower than expected.As the customer was unable to provide further information, a definite root cause analysis is not possible.Based on the data provided, the investigation could not identify a clear root cause.

• 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: 18451285
• MDR Text Key: 332177988
• Report Number: 1823260-2024-00042
• Device Sequence Number: 1
• Product Code: DHA
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• 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: 70917405
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1