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

Catalog Number 6802301

Device Problems Incorrect Or Inadequate Test Results (2456); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible and higher than expected troponin i result was obtained from a patient sample processed using vitros troponin i es reagent with a vitros 5600 integrated system.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tropi es reagent issue was not a likely contributor to the event.However, the customer does not process a control fluid with a troponin i concentration at or below the url.Therefore, the performance of the vitros tropi es reagent at or below the url concentration of 0.034 ng/ml cannot be determined and a reagent issue could not be entirely ruled out as contributing to the event.Vitros tropi es precision testing performed was within acceptable guidelines, indicating an instrument issue was not a contributing factor.In addition, pre-analytical sample processing could not be ruled out as a contributing factor, as the customer was not 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 troponin i es result from a patient sample processed using vitros troponin i es reagent in combination with a vitros 5600 integrated system.Vitros troponin i es = 0.175 ng/ml versus expected <0.012 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected troponin i es result was reported from the laboratory, however, sample testing was repeated and a corrected report was issued for the affected sample.There were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7559975
• MDR Text Key: 110478532
• Report Number: 3007111389-2018-00074
• Device Sequence Number: 1
• Product Code: MMI
• 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: 06/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/19/2018
• Device Catalogue Number: 6802301
• Device Lot Number: 2861
• Other Device ID Number: 1075850002504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2018
• 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