MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS SHBG; SEX HORMONE BINDING GLOBULIN ASSAY

Catalog Number 03052001190

Device Problems Low Test Results (2458); Output Problem (3005); Non Reproducible Results (4029)

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

Event Date 01/06/2024

Event Type  malfunction  

Event Description

The initial reporter received questionable elecsys shbg results from multiple patient samples tested on the cobas 8000 - cobas e 602 module.The reporter was able to provide two examples of discrepant results: sample 1 on 06-jan-2024, the initial result was 1.64 nmol/l.This result was reported to the doctor.On 10-jan-2024, the repeat result was 26.99 nmol/l.Sample 2 on 07-jan-2024, the initial result was 4.00 nmol/l.This result was reported to the doctor.The first repeat result was 3.99 nmol/l.On 10-jan-2024, the repeat result was 60.03 nmol/l.The repeat results were deemed correct. .

Manufacturer Narrative

The serial number of the customer's cobas 8000 - cobas e 602 module is 14a6-04.The investigation is ongoing.

• Brand Name: ELECSYS SHBG
• Type of Device: SEX HORMONE BINDING GLOBULIN ASSAY
• 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: 18621373
• MDR Text Key: 334808078
• Report Number: 1823260-2024-00287
• Device Sequence Number: 1
• Product Code: CDZ
• Combination Product (y/n): Y
• Reporter Country Code: BR
• PMA/PMN Number: K102814
• 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: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 03052001190
• Device Lot Number: 664114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2024
• 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