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

Catalog Number 6802301

Device Problems High Readings (2459); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/05/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, higher than expected, vitros tropi es result was obtained from a single patient sample when tested on a vitros eciq immunodiagnostic system.A definitive assignable cause could not be determined.Based on the historical trop ies quality control performance, a vitros tropi es reagent issue is not a likely contributing factor to this event.However, given the fact the level 1 control does not adequately evaluate performance of the vitros tropi es reagent for sample with troponin i concentrations < url (0.034 ng/ml), a reagent issue cannot be entirely ruled out as a contributing factor.An instrument related issue cannot be ruled out as a contributing factor as precision testing to evaluate vitros instrument performance was not performed.Pre analytical sample processing could not be ruled out as a contributing factor, as it was unknown if the customer was processing the samples in accordance with the sample collection device manufacturer¿s recommendations for sample centrifugation.It is likely that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

The customer obtained a non-reproducible, higher than expected result from a single patient sample processed on a vitros eciq immunodiagnostic system using vitros tropi es reagent.Sample 1 result of 01.92 ng/ml versus the expected result of < 0.012 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected result was reported outside of the laboratory, however a corrected report was subsequently issued.No treatment was altered, initiated or stopped based on the reported result.Ortho was not made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc., complaint numbers (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: 7382920
• MDR Text Key: 104152318
• Report Number: 3007111389-2018-00045
• Device Sequence Number: 1
• Product Code: MMI
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2018
• Device Catalogue Number: 6802301
• Device Lot Number: 2790
• Other Device ID Number: 10758750002504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2017
• 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