FDA Adverse Event Malfunction Summary report: N

VITROS 350 CHEMISTRY SYSTEM

MDR report key: 18438888 · Received January 3, 2024

Report

Report Number: 0001319681-2024-00002
Event Type: Malfunction
Date Received: January 3, 2024
Date of Event: December 7, 2023
Report Date: January 3, 2024
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Code: JJE
UDI-DI: 10758750002054
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE INVESTIGATION DETERMINED THAT THE SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TEST WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. THE ASSIGNABLE CAUSE OF THE EVENT WAS DETERMINED TO BE USER ERROR. THE VITROS 350 INSTRUMENT WAS OPERATING AS INTENDED. THE CUSTOMER REUSED A SAMPLE ID WITHOUT ENSURING THE PREVIOUSLY PROGRAMMED SAMPLE ID WAS PROCESSED TO COMPLETION OR DELETED PRIOR TO REUSE.

Description of Event or Problem · 0

A CUSTOMER CONTACTED THE ORTHO CLINICAL DIAGNOSTICS (ORTHO) TECHNICAL SOLUTION CENTER (TSC) TO REPORT A SAMPLE ID FOR A PATIENT SAMPLE WAS ASSOCIATED WITH THE INCORRECT PATIENT NAME AND TEST WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. BIASED RESULTS OF THE MAGNITUDE AND DIRECTION OBSERVED MAY LEAD TO INAPPROPRIATE PHYSICIAN ACTION IF THEY WERE TO OCCUR UNDETECTED. THE CUSTOMER IDENTIFIED THE DISCREPANCY, AND NO ERRONEOUS RESULTS WERE REPORTED OUT OF THE LABORATORY. THERE WAS NO ALLEGATION OF PATIENT HARM AS A RESULT OF THIS EVENT. THIS REPORT CORRESPONDS TO ORTHO CLINICAL DIAGNOSTICS INC (ORTHO) COMPLAINT NUMBER (B)(4) AND REPORTABILITY ASSESSMENT 604492.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1574622	VITROS 350 CHEMISTRY SYSTEM	CHEMISTRY ANALYZER	JJE	ORTHO-CLINICAL DIAGNOSTICS, INC.			10758750002054

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown