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 10/05/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros glucose (glu) result was obtained from a patient sample while using vitros glu slides lot 0031-0928-7830 when tested on a vitros 5600 integrated system.The likely cause of the lower than expected vitros glu results is an issue related to the vitros 5600 system.Multiple assays results were affected indicating the issue is related to the analyzer performance and not the performance of vitros glu lot 0031-0928-7830.Only the vitros glu result breached ortho's reporting criteria.Diagnostic within run precision testing was not performed prior to service actions.However, at the time of this report, micro slide metering condition codes persist indicating service actions performed have not resolved the issue.Further service is needed to return the vitros 5600 system to the expected performance.In addition, an investigation has been initiated to determine why assay results were not suppressed at the time of the metering condition codes.The investigation is ongoing.The most likely assignable cause of this event was concluded to be an instrument issue.

Event Description

A customer observed a non-reproducible, lower than expected vitros glucose (glu) result obtained from a patient sample while using vitros glu slides lot 0031-0928-7830 when tested on a vitros 5600 integrated system.Patient 2 sample vitros glu result of <1.11 mmol/l versus the expected glu result 10.59 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The non-reproducible, lower than expected, vitros glu result was not reported outside of the laboratory and there was no allegation of actual patient harm as a result of this event.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.(b)(4).

Manufacturer Narrative

As noted in the initial report issued on 30 october 2017, an ortho customer complained after obtaining a lower than expected result from a patient sample processed using vitros chemistry products glu slides in combination with their vitros 5600 integrated system.The likely cause of the event is the incorrect positioning of the sample metering proboscis on a vitros 5600 system that was not detected causing erroneous results to be obtained for a patient sample.Due to hardware reliability issue (i.E.X- drive assembly coupling used for sample metering assembly) and its associated adjustment, the sample metering proboscis may not dispense sample fluid in the correct location.When this condition occurs, vitros 5600 analyzer codes te1-504, 594 are produced by the vitros 5600, however, the vitros 5600 analyzer¿s sample dispense pressure profile does not detect the malfunction.Therefore, believable, erroneous results are reported by the vitros 5600 analyzer.The fda new york district office was notified of this issue on 17 august 2018.Refer to report number 1319681 08/17/2018 001 c.

Event Description

This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers (b)(4) / qerts record id (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: 6989472
• MDR Text Key: 91454389
• Report Number: 1319681-2017-00097
• Device Sequence Number: 0
• Product Code: CFR
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 09/04/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2017
• Is this an Adverse Event Report?: No
• 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: 10/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2010
• 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