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); Low Test Results (2458)

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

Event Date 01/30/2024

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 disk serial number was (b)(6).Qc was acceptable on the day of the event.The investigation is ongoing.

Event Description

We received an allegation about discrepant results for 1 patient's serum/plasma sample tested with elecsys hcg+beta (hcg+b) assay on a cobas e411 immunoassay analyzer when compared to an unknown manufacturer at an external laboratory.The initial result was >10000 miu/ml (accompanied by a data flag).The sample was repeated with an automatic dilution of 1:100 and the 1st repeat result was approximately 14900 miu/ml.The sample was then sent to an external laboratory for cross-checking and the 2nd repeat result was approximately 23000 miu/ml.On 31-jan-2024 the sample was repeated twice on the cobas e411 with an automatic dilution of 1:2 and the results were 16726 miu/ml and 16152 miu/ml.No questionable result was reported outside the laboratory.The repeat results on cobas e411 were deemed to be correct.

• 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: 18741976
• MDR Text Key: 336788155
• Report Number: 1823260-2024-00494
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): Y
• Reporter Country Code: GR
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 02/26/2024
• 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