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

Catalog Number 1896836

Device Problem High Readings (2459)

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

Event Date 08/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that discordant, higher than expected vitros troponin i es (tropi es) and vitros ck-mb results were obtained from multiple samples from the same patient when tested using vitros immunodiagnostic products troponin i es reagent and vitros immunodiagnostic products ck-mb reagent on a vitros 5600 integrated system.The results did not correlate when compared to alternative methods.A definitive assignable cause could not be determined.Based on historical quality control results, a vitros tropi es lot 3150 performance issue is 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 lot 3150 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.A vitros ck-mb lot 2520 cannot be ruled out as a contributor to the event as quality control results prior to the event were not within acceptable guidelines.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros tropi es reagent lot 3150 or vitros ck-mb reagent lot 2520.The customer declined to perform precision testing on the vitros 5600 integrated system.However, there is no evidence to suggest that the vitros 5600 integrated system malfunctioned and maintenance records suggests an instrument issue was not likely a contributing factor.Pre-analytical sample processing could not be ruled out as a contributing factor.The customer is not following the manufacturer¿s recommendation for sample centrifugation.Therefore, improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The customer believes the high results are most likely due to an heterophilic antibody or unknown interferent.A possible cause for the elevated results is an unknown sample interferent, but this was not confirmed.

Event Description

A customer reported discordant, higher than expected vitros troponin i es (tropi es) and vitros ck-mb results obtained from multiple samples from the same patient when tested using vitros immunodiagnostic products troponin i es reagent and vitros immunodiagnostic products ck-mb reagent on a vitros 5600 integrated system.The results did not correlate when compared to alternative methods.Patient 1 vitros tropi es results of 0.232, 0.223, 0.214 and 0.258 ng/ml vs.The beckman troponin i result of 0 ng/ml and the abbott troponin i result of 0.001 ng/ml patient 1 vitros ck-mb results of 27.6, 22.8, 24.3 and 30.7 ng/ml vs.The beckman ck-mb result of 1.2 ng/ml and the abbott ck-mb result of 0.92 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 vitros tropi es and vitros ck-mb results were reported from the laboratory.However, no treatment was altered, initiated or stopped based on the reported results.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 3 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.This report corresponds to ortho clinical diagnostics inc.(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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9007723
• MDR Text Key: 219762764
• Report Number: 3007111389-2019-00144
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/18/2019
• Device Catalogue Number: 1896836
• Device Lot Number: 2520
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2019
• 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