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

Catalog Number 1896836

Device Problem Low Test Results (2458)

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

Event Date 01/14/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros ck-mb result from a non-vitros mas thermofisher quality control (qc) fluid was attained using vitros ck-mb reagent in combination with a vitros 5600 integrated system.A definitive assignable cause could not be determined.An issue relating to the performance of vitros ck-mb reagent lot 2430 could not be ruled out as a contributor to the event.The customer was not processing both levels of mas qc fluids on a daily basis leading up to the event; therefore, the daily performance of the reagent was not verified by the customer.The customer¿s baseline mean was considerably lower than the package insert mean for the mas xl1 fluid and the customer¿s historical qc results leading up to the event were also lower than their baseline mean.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb reagent lot 2430.Due to the reoccurrence of low mas qc fluid results obtained by the customer, ortho recommended the customer contact thermofisher to discuss the stability of the mas qc fluids.Ortho sent the customer cliniqa qc fluids and alternative vitros ck-mb lot 2430 reagent packs.The customer has since run three levels of cliniqa fluids, on a daily basis on alternative packs, and the results have shown acceptable accuracy and within laboratory precision.An ortho field engineer visited the customer site to verify the performance of the vitros 5600 integrated system.However, no pre or post-service precision testing was conducted on the vitros 5600 integrated system.Therefore, the performance of the instrument was not verified and cannot be ruled out as a contributor to the event.Furthermore, ortho was able to determine that the customer was not following the correct procedures for weekly maintenance relating to the microwell incubator.Incubator contamination could have contributed to the event, but this could not be confirmed.

Event Description

A customer reported a lower than expected vitros ck-mb result obtained from a non-vitros mas thermofisher quality control (qc) fluid using vitros immunodiagnostics products ck-mb reagent in combination with a vitros 5600 integrated system.Mas xl1 vitros ck-mb result of 3.218 ng/ml versus the customer¿s estimated baseline mean of 4.43 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 result stemmed from a qc fluid, however, the investigation could not confirm that patient samples would not be affected if the event were to recur undetected.There were no allegations 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 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: 8322599
• MDR Text Key: 138221041
• Report Number: 3007111389-2019-00027
• Device Sequence Number: 1
• Product Code: JHX
• 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: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2019
• Device Catalogue Number: 1896836
• Device Lot Number: 2430
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2018
• 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