MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS; IN VITRO DIAGNOSTICS

Catalog Number 1286293

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/28/2019

Event Type  Injury  

Manufacturer Narrative

The investigation concludes that an operator splashed vitros immunodiagnostic products ck-mb calibrator fluid in their eye while handling the product.The assignable cause of this event is user error.The operator did not use personal protective equipment (eye protection or face shield) while interacting with a potentially infectious material.The investigation concluded that since the ck-mb material in the calibrator fluid is of human origin, it should be considered potentially infectious and the potential for a blood borne pathogen infection due to the event cannot be ruled out.However, based on a previous medical consult with an ortho medical safety officer for a similar event, because the affected vitros operator immediately flushed their eye with water after the incident, the likelihood of this operator to be infected with a pathogen due to this incident should be very low.

Event Description

A customer reported an incident in which an operator was splashed in the eye by fluid from a vitros immunodiagnostic products ck-mb calibrator.The operator was not wearing the appropriate personal protective equipment (eye protection or face shield).Per the vitros ck-mb instructions for use: warning: potentially infectious material.The vitros ck-mb calibrators contain products of human origin.Treat as if capable of transmitting infection.Use caution when handling material of human origin.Consider all samples potentially infectious.No test method can offer complete assurance that hepatitis b virus, hepatitis c virus (hcv), human immunodeficiency virus (hiv 1+2) or other infectious agents are absent.Handle, use, store and dispose of solid and liquid waste from samples and test components, in accordance with procedures defined by appropriate national biohazard safety guideline or regulation (e.G.Clsi document m29).The vitros operator had no adverse reactions or symptoms as a result of this event, and no additional medical treatment was sought.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4) / ivd (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB CALIBRATORS
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9235193
• MDR Text Key: 173185376
• Report Number: 3007111389-2019-00168
• Device Sequence Number: 1
• Product Code: JIS
• 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: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2019
• Device Catalogue Number: 1286293
• Device Lot Number: 2510
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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