MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CKMB SLIDES; IN VITRO DIAGNOSTICS

Catalog Number 8058232

Device Problem High Test Results (2457)

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

Event Date 08/06/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, higher than expected ckmb results were obtained from a single patient sample when processed using vitros ckmb slides lot 4948-0234-6019 on a vitros 5600 integrated system.A definitive cause of the event was not established with the information provided.A vitros ckmb lot 4948-0234-6019 slide issue cannot be ruled out as a contributor to the event, as quality control results around the time of the event showed inaccuracy but other vitros ckmb results between lots showed concordance with other patient samples.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ckmb lot 4948-0234-6019.An instrument issue cannot be ruled out as a contributor to the event, as no diagnostic precision test was carried out to verify instrument performance when requested.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as it could not be determined whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.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.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report discordant, higher than expected vitros ckmb results from a patient sample when tested using vitros ckmb slides on a vitros 5600 integrated system.Patient 1 results of 18 u/l and 20 u/l versus the expected result of 10 u/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros ckmb results were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number 1 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10474367
• MDR Text Key: 246656257
• Report Number: 1319809-2020-00088
• Device Sequence Number: 1
• Product Code: JHS
• 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: 08/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 8058232
• Device Lot Number: 4948-0234-6019
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2019
• 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