MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 6802301

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 12/19/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant vitros tropi es results were obtained from multiple samples from a single patient when compared to an alternative vitros troponin reagent lot and to a non-vitros method processed on a vitros eci immunodiagnostic system.The customer did not provide any historical quality control results; however, the customer reported that qc fluid performance over the testing period was acceptable; therefore, a vitros tropi es reagent issue is unlikely.As the results were consistently high over a two week period and there was no indication that any other patient samples were affected, a calibration or instrument issue is unlikely to be a contributing factor.The most likely assignable cause of the discordant vitros tropi es results is a sample interferent such as human anti mouse antibody (hama) or heterophilic antibody.

Event Description

A customer observed discordant vitros tropi es results from multiple samples from a single patient when compared to an alternative vitros troponin reagent lot and to a non-vitros method, processed using a vitros troponin i es reagent in combination with a vitros eci immunodiagnostic system.Patient results 10.1, 19.2, 26.2, 21, 20.9, 16.6, 19.8, 13.7, 22, 13, 11, 17, 14.8, 11.8, 15.3, 15.3, 18.2, 1.68, 1.95, 2.7, 1.91, 2.04, 1.75, 2.18, 3.45 versus expected result 0.01 ng/ml determined by a non-vitros method.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The discordant results were reported outside of the laboratory and the customer stated that medication was administered based on these results.Ortho has not been made aware of any allegation of patient harm.This report is number two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 7205757
• MDR Text Key: 98189878
• Report Number: 3007111389-2018-00008
• Device Sequence Number: 1
• Product Code: MMI
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/24/2018
• Device Catalogue Number: 6802301
• Device Lot Number: 2650
• Other Device ID Number: 10758750002504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2017
• 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): Hospitalization