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

Catalog Number 03300811190

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/04/2020

Event Type  malfunction  

Manufacturer Narrative

This event occurred in (b)(6).On (b)(6) 2020 the field service engineer (fse) visited the customer site and did not identify an issue.The fse completed instrument performance testing and verified the alignments for various parts of the instrument.Instrument test results were within specification and qc was acceptable.

Event Description

The initial reporter complained of a low result not corresponding to the clinical picture for 1 patient tested for elecsys hcg stat (hcg stat) on a cobas e 411 immunoassay analyzer.On (b)(6) 2020 the hcg stat result from an e601 module at a different site was 9910 miu/ml.On (b)(6) 2020 the result from the customers e411 analyzer using a new sample was 6.45 miu/ml with a data flag.This result was reported outside of the laboratory where it was questioned as the patient is pregnant.The e411 analyzer serial number was (b)(4).

Manufacturer Narrative

Neither a general instrument or reagent issue were identified.The investigation did not identify a product problem.The cause of the event could not be determined.

• Brand Name: ELECSYS HCG TEST SYSTEM
• Type of Device: SYSTEM, TEST, HUMAN CHORIONIC GONADOTROPIN
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11012968
• MDR Text Key: 221763250
• Report Number: 1823260-2020-03210
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• PMA/PMN Number: K002148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Catalogue Number: 03300811190
• Device Lot Number: 45804501
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/20/2020
• Initial Date FDA Received: 12/15/2020
• Supplement Dates Manufacturer Received: 11/20/2020
• Supplement Dates FDA Received: 01/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 21 YR