FDA Adverse Event Malfunction Summary report: N

VITROS 350 CHEMISTRY SYSTEM

MDR report key: 16709493 · Received April 10, 2023

Report

Report Number: 0001319681-2023-00021
Event Type: Malfunction
Date Received: April 10, 2023
Date of Event: March 13, 2023
Report Date: April 10, 2023
Manufacturer: ORTHO-CLINICAL DIAGNOSTICS, INC.
Product Code: JJE
UDI-DI: 10758750002054
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

WITH THE INFORMATION PROVIDED BY THE CUSTOMER, THE INVESTIGATION DETERMINED THAT THE SIDS FOR MULTIPLE PATIENT SAMPLES WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES AND ASSAYS WHEN PROCESSED ON A VITROS 350 CHEMISTRY SYSTEM. THE MOST LIKELY CAUSE OF THE EVENT WAS USER ERROR. THE VITROS 350 CHEMISTRY SYSTEM WAS OPERATING AS INTENDED. THE CUSTOMER REUSED SIDS WITHOUT ENSURING THE PREVIOUSLY PROGRAMMED SIDS WERE 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 THE SIDS FOR MULTIPLE PATIENT SAMPLES WERE ASSOCIATED WITH THE INCORRECT PATIENT NAMES AND ASSAYS 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. 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 (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1853257	VITROS 350 CHEMISTRY SYSTEM	CHEMISTRY ANALYZER	JJE	ORTHO-CLINICAL DIAGNOSTICS, INC.	6802153		10758750002054

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown