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

Catalog Number 03271749160

Device Problems False Positive Result (1227); Incorrect, Inadequate or Imprecise Result or Readings (1535); High Test Results (2457)

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

Event Date 03/15/2022

Event Type  malfunction  

Event Description

The initial reporter stated they received questionable results for two samples collected from the same patient and tested with the elecsys hcg + beta test system ver.2 on a cobas e 411 immunoassay analyzer.The sample values were reported outside of the laboratory and questioned since they did not agree with the clinical status of the patient.The first sample resulted in an hcg+beta value of 24.89 miu/ml.The second sample resulted in an hcg+beta value of 27.52 miu/ml on (b)(6) 2022.The physician questioned the values since the patient has stated that she has not had sex in years and should not be pregnant.The patient does not take over the counter supplements such as biotin.The patient is not around any animals on a large scale.

Manufacturer Narrative

A sample from the patient was tested for hcg using the siemens method and the result was zero.

Manufacturer Narrative

The patient confirmed that she drinks protein shakes and these contain other vitamins and supplements.

Manufacturer Narrative

A sample from the patient was provided for investigation and the results obtained by the customer could be reproduced.

Manufacturer Narrative

Calibration and control data are acceptable.There is no indication of a reagent issue at the site.Further investigations of the provided patient sample with size exclusion chromatography determined that high-weight molecular interferences such as igms and iggs can be excluded.The analysis showed a peak at a molecular weight of approximately 37 kda, which is the expected size of intact hcg.The results indicate that the peak is caused by an hcg variant and/or a hyperglycolsylated hcg variant.

• Brand Name: ELECSYS HCG + BETA TEST SYSTEM
• 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; sandhoferstrasse 116; na; mannheim (baden-wurttemberg) 68305 ; GM 68305
• Manufacturer Contact: michael leslie ; 9115 hague road; na; indianapolis, IN 46250 ; 3175214343
• MDR Report Key: 14073010
• MDR Text Key: 298595862
• Report Number: 1823260-2022-00992
• Device Sequence Number: 1
• Product Code: DHA
• UDI-Device Identifier: 04015630939022
• UDI-Public: 04015630939022
• Combination Product (y/n): N
• 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,Followup,Followup,Followup
• Report Date: 11/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2022
• 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: 551036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• 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
• Patient Age: 40 YR
• Patient Sex: Female