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

Catalog Number 6802413

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 09/17/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that unexpected vitros amon results were obtained using two levels of non-vitros quality controls and a single level of vitros quality control tested on a vitros 5600 integrated system.The most likely assignable cause of the unexpected vitros amon quality control results is an instrument related issue.The results of amon within-run precision testing demonstrated that the vitros system was not operating as expected.Following service actions that optimized all subsystems of the vitros 5600 integrated system, including the replacement of evaporation caps and wear pads, along with all necessary adjustments, acceptable vitros amon performance was observed.

Event Description

The investigation determined unexpected ammonia results were obtained from two levels of a non-vitros biorad quality control fluids and a single level of vitros liquid performance verifier (lpv) when using vitros amon slides on a vitros 5600 integrated system.Br l2 lot 54162 vitros amon result of 105.0 umol/l versus expected 87.3 umol/l.Br l3 lot 54163 vitros amon result of 178.4, 58.2 and 97.5 umol/l versus expected 226.6 umol/l.Lpv l1 lot u4561 vitros amon result of 110.0 umol/l versus expected 37.6 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action, should they occur undetected on patient samples.The customer stated that patient samples were not processed during the timeframe the quality control results were outside of established ranges, however the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no reported allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(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: 6903893
• MDR Text Key: 89594659
• Report Number: 1319681-2017-00085
• Device Sequence Number: 0
• Product Code: JIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• 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?: Yes
• Date Manufacturer Received: 09/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1