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

Catalog Number 6802413

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 06/24/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower and higher than expected vitros amon results were obtained when testing non-vitros quality controls on a vitros 5600 integrated system.Biorad qc level 2 amon result 103.7 umol/l versus expected 75.5 umol/l.Biorad qc level 3 amon result of 15.7 umol/l versus expected 227.7 umol/l.The assignable cause of this event was instrument related most likely due to incubator contamination.The customer completed an incubator decontamination procedure including cleaning/replacing the incubator evaporation caps and slots, and returned the instrument to expected operation.Following this activity, acceptable vitros amon performance was observed.

Event Description

The customer observed lower and higher than expected vitros amon results when testing non-vitros quality control fluids on a vitros 5600 integrated system.Biorad qc level 2 amon result 103.7 umol/l versus expected 75.5 umol/l.Biorad qc level 3 amon result of 15.7 umol/l versus expected 227.7 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The vitros amon results were obtained when testing non-vitros quality control samples.However, the investigation cannot conclude that patient samples were not affected or 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: 6730324
• MDR Text Key: 80762643
• Report Number: 1319681-2017-00054
• 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: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2017
• 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: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/28/2012
• 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