MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS 5600 INTEGRATED SYSTEM CHEMISTRY ANALYZER

Catalog Number 6802413

Device Problem High Test Results (2457)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/11/2016

Event Type  Malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected amon results were obtained from non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. A likely assignable cause for the higher than expected amon results is user error due to pre-analytical sample handling. Acceptable performance was obtained when fresh pours of control fluids that were properly handled were retested. There was no indication the vitros amon reagent or the vitros 5600 system malfunctioned.

Event Description

The customer obtained higher than expected amon results from two levels of non vitros quality control fluids using vitros amon reagent on a vitros 5600 integrated system. Level 1 vitros amon result 112 umol/l versus the expected amon result 80. 3 umol/l level 2 vitros amon result 301 umol/l versus the expected amon result 212 umol/l biased results of the direction and magnitude observed may lead to inappropriate physician action. The customer stated that vitros amon patient samples were not processed during the time frame of the event. However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected. There was no allegation of patient harm as a result of this event. This report corresponds to ortho clinical diagnostics inc. Complaint number (b)(4).

• Brand Name: VITROS 5600 INTEGRATED SYSTEM
• Type of Device: CHEMISTRY ANALYZER
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 5442829
• MDR Text Key: 38998801
• Report Number: 1319681-2016-00029
• Device Sequence Number: 0
• Product Code: JIF

Combination Product (Y/N)

• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: HEALTH PROFESSIONAL

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/17/2016

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 02/17/2016
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device Catalogue Number: 6802413
• Was Device Available For Evaluation?: Yes
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/22/2016
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 01/25/2010
• Is The Device Single Use?: No
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse