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

Catalog Number 1896836

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that higher than expected vitros ck-mb results were obtained from three different samples drawn from a single patient using vitros immunodiagnostics product ck-mb reagent pack on a vitros 5600 integrated system.The assignable cause for the higher than expected vitros ck-mb results for the patient is the presence of a heterophilic sample interferent present in the three patient samples tested.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros ck-mb reagent lot 2910.Email address for contact office is (b)(4).

Event Description

The investigation has determined that higher than expected vitros ck-mb results were obtained from three different samples collected from a single patient using vitros immunodiagnostics product ck-mb reagent lot 2910 on a vitros 5600 integrated system.The three samples were collected over three consecutive dates.Patient results = 14.6, 14.5, 14.5, 14.2 and 14.5 ng/ml versus the expected result of 1.7 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros ck-mb results were reported from the laboratory.Based on the reported vitros ck-mb results a medical procedure was delayed, however, no other details regarding the medical procedure were given upon request.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11734591
• MDR Text Key: 265023186
• Report Number: 3007111389-2021-00062
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2021
• Device Catalogue Number: 1896836
• Device Lot Number: 2910
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2020
• 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