MAUDE Adverse Event Report: ROCHE DIAGNOSTICS ELECSYS DHEA-S; DEHYDROEPIANDROSTERONE TEST SYSTEM

Model Number DHEAS

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

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

Event Date 03/18/2021

Event Type  malfunction  

Manufacturer Narrative

This investigation is ongoing.This event occurred in (b)(6).Unique identifier (udi) #: (b)(4).

Event Description

The initial reporter received questionable elecsys dhea-s and elecsys ft3 iii results for one patient with the cobas e 801 module serial number (b)(4) compared to two different competitors' analyzers.This medwatch will cover dhea-s.Refer to medwatch with patient identifier (b)(6) for information on the ft3 iii results.The dhea-s result from the e801 was 4.42 ug/ml.The result from the siemens analyzer was 1.66 ug/ml.The questionable result was reported outside of the laboratory.

Manufacturer Narrative

The calibration and qc were acceptable.Further investigations were performed on the patient sample.A streptavidin interfering factor was confirmed within the sample leading to false-high results for elecsys dhea-s.Product labeling states: 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.The product meets specifications.

• Brand Name: ELECSYS DHEA-S
• Type of Device: DEHYDROEPIANDROSTERONE TEST SYSTEM
• Manufacturer (Section D): ROCHE DIAGNOSTICS; 9115 hague road; indianapolis IN 46250 0457
• MDR Report Key: 11679637
• MDR Text Key: 248178899
• Report Number: 1823260-2021-01161
• 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: 05/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: DHEAS
• Device Catalogue Number: 07027192190
• Device Lot Number: 463341
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 55 YR