FDA Adverse Event Malfunction Summary report: N

COBAS E 411 ANALYZER (DISK SYSTEM)

MDR report key: 22202437 · Received June 13, 2025

Report

Report Number: 1823260-2025-01830
Event Type: Malfunction
Date Received: June 13, 2025
Date of Event: May 21, 2025
Report Date: June 13, 2025
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
UDI-DI: 04015630937103
PMA / PMN Number: K961481
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE REAGENT LOT NUMBER WAS 801753. THE EXPIRATION DATE WAS NOT PROVIDED. THE CUSTOMER FOUND THAT THE SAMPLE/REAGENT PROBE WAS MISALIGNED AND DROPPING TIPS INTO THE REAGENT PACKS. THE FIELD SERVICE ENGINEER FOUND THE SAMPLE/REAGENT PROBE NEEDED ADJUSTMENT. HE ADJUSTED THE PROBE AND CONFIRMED THERE WERE NO ISSUES OR ALARMS WHEN THE PROBE ASPIRATED THE REAGENT. THE INVESTIGATION DETERMINED THAT THE SERVICE ACTIONS RESOLVED THE ISSUE.

Description of Event or Problem · 0

THERE WAS AN ALLEGATION OF QUESTIONABLE ELECSYS PTH STAT IMMUNOASSAY RESULTS FROM THE COBAS E411 DISK. THE CUSTOMER ESTIMATED THE DATE OF THE EVENT WAS BETWEEN 21-MAY-2025 AND 28-MAY-2025. THE INITIAL PTH RESULT WAS 42 PG/ML. THIS VALUE WAS MUCH HIGHER THAN EXPECTED, AS THEY WERE TESTING 5-MINUTE INTERVAL SAMPLES DURING SURGERY, AND THIS SAMPLE WAS NEAR THE END OF TESTING, AND THE RESULT WAS HIGHER THAN THE PRIOR SAMPLE. THE SAMPLE WAS REPEATED, AND THE RESULT WAS 25 PG/ML. THIS RESULT AGREED WITH WHAT WAS EXPECTED. THE SAMPLE WAS ALSO REPEATED ON A COBAS 8000 SYSTEM, AND THE RESULT WAS 16 PG/ML.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
342061	COBAS E 411 ANALYZER (DISK SYSTEM)	IMMUNOCHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS	E 411		04015630937103

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown