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 08/07/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher and lower than expected phyt quality control results were obtained from a vitros tdm quality control fluid, three levels non-vitros biorad quality control fluids and a single patient sample while using vitros phyt reagent lot 2615-0163-0739 on a vitros 5600 integrated system.The most likely assignable cause is an instrument related issue.A vitros phyt within-run precision test was performed to assess instrument performance and the results were outside of ortho¿s recommended guidelines.Acceptable vitros dgxn within-run precision test results were obtained after an ortho field engineer replaced the iwf metering pump assembly and performed all necessary adjustments to the iwf sub-system of the vitros 5600 system.The most likely assignable cause of this event was concluded to be an instrument issue.

Event Description

A customer observed higher and lower than expected vitros phyt quality control results obtained from a vitros tdm quality control fluid, three levels non-vitros biorad quality control fluids and a single patient sample while using vitros phyt reagent lot 2615-0163-0739 on a vitros 5600 integrated system.Vitros tdm pv l5351 phyt result of 32.2 and 20.7 ug/ml vs.The expected result of 26.6 ug/ml.Biorad l1 control lot 40930 phyt result of 7.40 vs the expected blm result of 5.40 ug/ml; biorad l2 control lot 40930 phyt result of 15.55 vs the expected blm result of 12.9 ug/ml; biorad l3 control lot 40930 phyt results of 17.39, 14.35, 14.60, 15.97, 15.08, 17.25, 14.60 and 18.29 vs the expected blm result of 22.2 ug/ml.Patient sample 2 phyt result of 9.9 ug/ml vs expected result of 14 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.Patient samples were not tested for vitros phyt while quality control results were outside of expected ranges other than the patient sample correlation performed as part of the investigation.There was no allegation of actual patient harm as a result of this event.(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: 6841713
• MDR Text Key: 86762944
• Report Number: 1319681-2017-00074
• Device Sequence Number: 0
• Product Code: DIP
• Combination Product (y/n): N
• 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: 09/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2017
• 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: 08/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/25/2008
• 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