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

Catalog Number 6802413

Device Problem Low Test Results (2458)

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected quality control results were obtained on vitros myog reagent using non-vitros biorad quality control material on a vitros 5600 integrated system.It was concluded that the qc shift low was caused by an instrument issue as the same non-vitros biorad qc fluids were run on the customer¿s other analyzer without experiencing the same shift.A review of the historical qc results indicates qc performance was acceptable up until the day of the event.An ortho fe performed service actions including replacement of the reagent metering probe, inspections of the microwell incubator, and verification of adjustments to well wash, signal reagent, micro-immunoassay metering and luminometer subsystems.Acceptable myog qc performance has been maintained following service actions.

Event Description

The customer observed lower than expected quality control results on vitros myog reagent using non-vitros biorad quality control material on a vitros 5600 integrated system.(b)(6).The customer discontinued patient sample testing because quality control was unacceptable.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 harm.(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: 6894861
• MDR Text Key: 89468808
• Report Number: 1319681-2017-00084
• Device Sequence Number: 0
• Product Code: DDR
• 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: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• 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: 08/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2013
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1