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

Catalog Number 8058232

Device Problem Low Test Results (2458)

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb results were obtained when testing a single level of an unknown quality control fluid on a vitros 350 chemistry system.The definitive assignable cause of the lower than expected vitros ckmb results could not be determined.The control fluid the customer is using for routine vitros ckmb quality control testing was not provided; therefore it was not possible to verify performance for both accuracy and precision.In addition, no information was provided concerning the customer's fluid handling protocols.Therefore, it is possible the affected results are due to a pre-analytical sample handling issue, but this could not be confirmed with the information provided.Diagnostic within run precision testing was not performed to evaluate the vitros 350 system performance.Therefore an unexpected analyzer issue or an issue with vitros ckmb cannot be ruled out as contributing to the event.

Event Description

The customer observed negatively biased quality control results processed using vitros ckmb slides on a vitros 350 chemistry system.Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected.There was no report of patient harm as a result of this event.Unknown quality control fluid, vitros ckmb results 7.6 and 14.7 u/l versus the calculated mean 23.6 u/l.This report is number two of two 3500a forms filed for this event, as two 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 DIAGNOSTIC
• 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: 7862079
• MDR Text Key: 120738227
• Report Number: 1319809-2018-00110
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: SA
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8058232
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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