ELECSYS DHEA-S
Received Dec 22, 2025 · Event occurred Nov 24, 2025
Report 1823260-2025-05277 · MDR key 23865711
Device
Generic name
Dehydroepiandrosterone Test System
Manufacturer
Roche DiagnosticsModel number
DHEA-SCatalog number
07027192190
Lot number
857267
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Output Problem
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Low Test Results
- Output Problem
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
CALIBRATION AND QC WERE ACCEPTABLE. THE ALARM TRACE WAS REVIEWED, AND NO ALARMS RELATED TO THE EVENT WERE IDENTIFIED. THE SAMPLE WAS REQUESTED FOR INVESTIGATION, BUT COULD NOT BE PROVIDED. THE CUSTOMER DECLINED TO PROVIDE ANY ADDITIONAL PATIENT INFORMATION. THE INVESTIGATION DID NOT IDENTIFY A PRODUCT PROBLEM. THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.
Additional Manufacturer Narrative
THE E402 ANALYZER SERIAL NUMBER WAS (B)(6).
Description of Event or Problem
THE INITIAL REPORTER QUESTIONED RESULTS FOR 1 PATIENT SAMPLE TESTED FOR ELECSYS DHEA-S (DHEA-S) ON A COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS > 1000 G/DL WITH A DATA FLAG. THE REPEAT USING A 1:5 DILUTION WAS 113 G/DL; THE CALCULATED RESULT WAS 565 G/DL. THE MEASURING RANGE OF THE ASSAY IS 0.2 ¿ 1000 G/DL. THE CUSTOMER QUESTIONS WHY THE SAMPLE WOULD REQUIRE DILUTION, AS THE RESULT OF 565 G/DL WAS WITHIN THE MEASURING RANGE OF THE ASSAY. THE CUSTOMER SUSPECTS AN INTERFERENCE.