MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS ECI IMMUNODIAGNOSTIC SYSTEM; CHEMISTRY ANALYZER

Catalog Number 1922814

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected, vitros tropi es result was obtained from a single patient sample processed on a vitros eci immunodiagnostic system.The most likely assignable cause for the higher than expected result is instrument related.A bowl of bleach was found under an air conditioning unit adjacent to the vitros eci immunodiagnostic system.Sodium hypochlorite vapor is known to interfere with vitros assays that include vitros tropi es.Post cleaning and decontamination actions performed by an ortho field engineer, vitros tropi es qc fluids tested were within expected limits.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as it was not possible established if the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer obtained a non-reproducible, higher than expected, vitros tropi es result from a single patient sample processed on a vitros eci immunodiagnostic system.Patient sample result of 0.170 ng/ml versus the expected result of <0.012 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, higher than expected, vitros tropi es result was reported outside of the laboratory and anti-ischemic treatment was initiated on the patient.Per medical consult from an ortho medical safety officer, long term serious health impact due to this short-term exposure is not anticipated.A corrected report was later issued for the sample.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers: (b)(4).

• Brand Name: VITROS ECI IMMUNODIAGNOSTIC 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: 8515948
• MDR Text Key: 152940995
• Report Number: 1319681-2019-00030
• Device Sequence Number: 1
• Product Code: KHO
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1922814
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2007
• 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
• Patient Outcome(s): Other