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

Catalog Number 03271749190

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

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

The cobas e411 rack serial number was (b)(6).The lld (liquid level detection) voltage of the sample probe was incorrect.The field service engineer replaced the probe.A general reagent problem was not present, because the qc prior to the event was within ranges.The investigation is ongoing.

Event Description

There was an allegation of questionable hcg+beta elecsys cobas results from the cobas e411 rack analyzer.Sample 1: on (b)(6) 2023, the initial result was 15.65 mui/ml with a data flag and the repeat results using an aliquot were <0.1 mui/ml with a data flag and <0.1 mui/ml h a data flag.Sample 2 2: on (b)(6) 2023, the initial result was <0.1 mui/ml with a data flag and the repeat results were 1220 mui/ml and 1218 mui/ml.Sample 3: on (b)(6) 2023, the initial result was <0.1 mui/ml with a data flag and the repeat results were 902.8 mui/ml and 912.3 mui/ml.

Manufacturer Narrative

The investigation did not identify a product problem.The cause of the event could not be determined the issue appeared to be resolved after the service actions.

• 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: 18334247
• MDR Text Key: 330593603
• Report Number: 1823260-2023-04020
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): Y
• Reporter Country Code: VM
• 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: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: 12/22/2023
• 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
• Patient Sex: Female