FDA Adverse Event Malfunction Summary report: N

COBAS 6000 C (501) MODULE

MDR report key: 23179767 · Received September 30, 2025

Report

Report Number: 1823260-2025-03989
Event Type: Malfunction
Date Received: September 30, 2025
Date of Event: September 14, 2025
Report Date: September 30, 2025
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
PMA / PMN Number: K060373
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE CALCIUM REAGENT LOT NUMBER WAS 850567. THE REAGENT EXPIRATION DATE WAS REQUESTED, BUT NOT PROVIDED. CALIBRATION AND CONTROLS WERE ACCEPTABLE. A REVIEW OF THE ALARM TRACE DID NOT SHOW ANY RELEVANT ALARMS. THE FIELD SERVICE ENGINEER DETERMINED THERE WAS AN ISSUE WITH THE REAGENT PACK. THE PACK HAD ALREADY BEEN REPLACED BY THE CUSTOMER PRIOR TO REPEATING THE SAMPLES. THE ENGINEER PERFORMED A CHECK OF THE INSTRUMENT AND RAN MECHANISM CHECKS. CALIBRATION, CONTROLS, AND PRECISION STUDIES HAD VALID RESULTS. THE INVESTIGATION DETERMINED THE ISSUE WAS RESOLVED AFTER THE CUSTOMER AND SERVICE ACTIONS.

Description of Event or Problem · 0

THE INITIAL REPORTER STATED THEY RECEIVED DISCREPANT RESULTS FOR TWO PATIENT SAMPLES TESTED WITH CALCIUM GEN.2 ON A COBAS 6000 C (501) MODULE. THE CUSTOMER QUESTIONED THE INITIAL RESULTS, THEN REPLACED THE REAGENT PACK AND REPEATED THE SAMPLES. THE REPEAT RESULTS WERE DEEMED CORRECT. THE FIRST SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 5.3 MG/DL AND IT REPEATED AS 9.5 MG/DL. THE SECOND SAMPLE INITIALLY RESULTED IN A CALCIUM VALUE OF 4.8 MG/DL AND IT REPEATED AS 9.2 MG/DL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1586914	COBAS 6000 C (501) MODULE	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown