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 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined higher and lower than expected vitros phyt quality control results were obtained from two different quality control fluids on a vitros 5600 integrated system.The most likely assignable cause is instrument related, as the results of the phyt within-run precision tests were outside of ortho guidelines, indicating the vitros 5600 integrated system was not performing as intended.Ortho field service performed service actions to the immuno-wash subsystem, which included the replacement of the immunowash metering pump and performing all necessary adjustments.Acceptable phyt performance was obtained following these service actions.The investigation found no evidence the vitros phyt reagent malfunctioned.

Event Description

A customer observed higher and lower than expected vitros phyt quality control results obtained from two different levels of non-vitros biorad controls, lot 40912, on a vitros 5600 integrated system.Non-vitros br l2 lot 40912 vitros phyt results 9.9, 8.4, and 9.9 ug/ml versus the expected phyt result 12.58 ug/ml.Non-vitros br l3 lot 40913 vitros phyt results 30.8, 35.2, 29.7, 31.6, 34.3, 30.9, 28.8, 30.9, 34.5, 33.2, 36.6, 30.8, and 33.5 ug/ml versus the expected phyt result 23.48 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.Ortho was not made aware of any allegation of patient harm as a result of this event, however, the investigation could not rule out that patient samples were not, or would not be affected if the event were to recur undetected.(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: 6997925
• MDR Text Key: 92195888
• Report Number: 1319681-2017-00101
• Device Sequence Number: 0
• Product Code: DIP
• 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: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• 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?: No
• Date Manufacturer Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1