ELECSYS HCG+BETA
Received Jul 20, 2026 · Event occurred Jun 20, 2026
Report 1823260-2026-02931 · MDR key 25878418
Device
Generic name
System, Test, Human Chorionic Gonadotropin
Manufacturer
Roche DiagnosticsCatalog number
03271749190
Lot number
868696
Product problems
- Low Test Results
- Non Reproducible Results
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS HCG+BETA RESULTS FOR 1 PATIENT ON A COBAS E 411 ANALYZER (DISK SYSTEM).ON (b)(6) 2026, THE INITIAL RESULT WAS 77.30 MIU/ML WITH FLAG.ON (b)(6) 2026, A NEW SAMPLE WAS COLLECTED FROM THE PATIENT AND THE RESULT WAS 10000 MIU/ML WITH FLAG.THE NEW SAMPLE WAS DILUTED AND REPEATED TWICE AND THE RESULTS WERE 16.53 MIU/ML WITH FLAG AND 26447 MIU/ML WITH FLAG.THE SAMPLE WAS REPEATED WITHOUT DILUTION AND THE RESULT WAS >10000 MIU/ML WITH FLAG.THE SAMPLE WAS DILUTED AGAIN AND THE RESULT WAS 26962 MIU/ML WITH FLAG.THE INITIAL SAMPLE FROM (b)(6)2026 WAS REPEATED AND THE RESULT WAS >10000 MIU/ML WITH FLAG.THE INITIAL SAMPLE WAS DILUTED AND REPEATED AND THE RESULT WAS 32865 MIU/ML WITH FLAG.
Additional Manufacturer Narrative
THE ANALYZER SERIAL NUMBER IS (b)(6).THE QC RECOVERY DATA PROVIDED WAS WITHIN SPECIFICATION.THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND REPLACED TUBING.THE INVESTIGATION IS ONGOING.