MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DHEA-S; DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM

Catalog Number 03000087122

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/02/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is currently ongoing.The event occurred in: (b)(6).

Event Description

The initial reporter complained of a questionable elecsys dhea-s result for 1 patient tested on a cobas 8000 e 801 module compared to a beckman coulter, abbott architect, and siemens advia centaur.The dhea-s result from the cobas e801 was >1000 ug/dl with a data flag.The dheas results from the competitor system were: beckman coulter 358.9 ug/dl, abbott architect 366.2 ug/dl, and siemens advia centaur 347.6 ug/dl.The result in question was reported outside of the laboratory to the patient.The cobas e801 serial number is (b)(4).

Manufacturer Narrative

The customer provided two samples for investigation.Investigation of the samples confirmed an immunoglobulin was present that reacts with the reagent and affects the sample results.This type of interference is addressed in the product labeling: "in rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidin or ruthenium can occur.These effects are minimized by suitable test design.".

• Brand Name: ELECSYS DHEA-S
• Type of Device: DEHYDROEPIANDROSTERONE (FREE AND SULFATE) TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 8920145
• MDR Text Key: 177996488
• Report Number: 1823260-2019-03075
• Device Sequence Number: 1
• Product Code: JKC
• Combination Product (y/n): N
• PMA/PMN Number: K003174
• 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: 10/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 03000087122
• Device Lot Number: 38545800
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1