FDA Adverse Event Malfunction Summary report: N

COBAS 6000 C501 MODULE

MDR report key: 20631344 · Received November 7, 2024

Report

Report Number: 1823260-2024-03216
Event Type: Malfunction
Date Received: November 7, 2024
Date of Event: October 11, 2024
Report Date: December 19, 2024
Manufacturer: ROCHE DIAGNOSTICS
Product Code: JJE
UDI-DI: 04015630924707
PMA / PMN Number: K060373
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SF
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE REAGENT LOT NUMBER IS 801081. THE EXPIRATION DATE WAS NOT PROVIDED. THE FIELD SERVICE ENGINEER (FSE) OBSERVED TRACES OF SAMPLE TUBE SEPARATOR GEL WAS FOUND ON THE SAMPLE PROBE AND A KNICK IN THE TUBING FROM THE PRESSURE SENSOR TO THE SAMPLE SYRINGE. THE INVESTIGATION IS ONGOING.

Additional Manufacturer Narrative · 0

THE INVESTIGATION DETERMINED THE ISSUE WAS DUE TO PRE-ANALYTICAL HANDLING ISSUES AT THE CUSTOMER SITE. CORRECT PRE-ANALYTIC SAMPLE HANDLING IS WITHIN THE CUSTOMER'S RESPONSIBILITY. THERE IS NO EVIDENCE TO SUGGEST A MALFUNCTION OF THE DEVICE.

Description of Event or Problem · 0

THERE WAS AN ALLEGATION OF QUESTIONABLE CREP2 CREATININE PLUS VER.2 RESULTS FOR 3 PATIENT SERUM SAMPLE ON A COBAS 6000 C501 MODULE. ON (B)(6) 2024, SAMPLE 1 HAD AN INITIAL RESULT OF 258 UMOL/L WITH FLAG. ON (B)(6) 2024, THE SAMPLE WAS REPEATED TWICE AND THE RESULTS WERE 62 UMOL/L AND 66 UMOL/L. ON (B)(6) 2024, SAMPLE 2 HAD AN INITIAL RESULT OF 509 UMOL/L AND A REPEAT RESULT OF 116 UMOL/L. ON (B)(6) 2024, SAMPLE 3 INITIAL RESULT OF 649 UMOL/L AND A REPEAT RESULT OF 55 UMOL/L. THE REPEAT RESULTS WERE DEEMED CORRECT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1625394	COBAS 6000 C501 MODULE	CLINICAL CHEMISTRY ANALYZER	JJE	ROCHE DIAGNOSTICS			04015630924707

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR	Female