ELECSYS DHEA-S
Received Apr 4, 2025 · Event occurred Mar 7, 2025
Report 1823260-2025-01007 · MDR key 21772689
Device
Generic name
Dehydroepiandrosterone Test System
Manufacturer
Roche DiagnosticsCatalog number
07027192190
Lot number
790997
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
- Incorrect, Inadequate or Imprecise Result or Readings
- High Test Results
- Non Reproducible Results
Patient
14 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
QC WAS IN RANGE PRIOR TO THE EVENT. THERE WEREN'T ANY RELEVANT INSTRUMENT ALARMS OR SAMPLE QUALITY ALARMS ON THE DAY OF THE EVENT THE INVESTIGATION WAS UNABLE TO DETERMINE A DIRECT ROOT CAUSE.
Description of Event or Problem
THERE WAS AN ALLEGATION OF A QUESTIONABLE ELECSYS DHEA-S RESULT FROM THE COBAS E 402 ANALYTICAL UNIT. THE INITIAL RESULT WAS 407.0 UG/DL, AND THE REPEAT RESULT WAS 221 UG/DL. THE QUESTIONABLE RESULT WAS REPEATED BECAUSE THE CUSTOMER NOTICED THAT IT WAS VERY HIGH FOR THE PATIENT'S AGE, AND IT WAS NOT RELEASED TO THE PATIENT.
Additional Manufacturer Narrative
THE COBAS E 402 ANALYTICAL UNIT SERIAL NUMBER IS (B)(6). THE INVESTIGATION IS ONGOING.