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

Catalog Number 6802413

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected ammonia quality control result was obtained from a non-vitros quality control fluid using vitros amon reagent with a vitros 5600 integrated system.The most likely assignable cause of the lower than expected quality control result is instrument related.Vitros amon precision testing performed was outside of ortho guidelines, indicating that the vitros 5600 integrated system was not performing as intended at the time of the events.The cause of the unexpected instrument performance is likely due to microslide incubator contamination.An ortho clinical diagnostics field engineer performed service actions to return the vitros 5600 integrated system to expected performance.Following these service actions, acceptable vitros amon performance was observed.

Event Description

A customer obtained a lower than expected ammonia quality control result (114.79 umol/l vs.Expected result of 162.8 umol/l) from a non-vitros quality control fluid, using vitros amon reagent with a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected ammonia result was generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the 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: 5485753
• MDR Text Key: 40136913
• Report Number: 1319681-2016-00044
• Device Sequence Number: 0
• Product Code: JIF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2016
• 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
• Date Manufacturer Received: 02/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1