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 07/26/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected, vitros ckmb results were obtained when testing a vitros isoenzyme performance verifier control on a vitros 5600 integrated system.The definitive assignable cause could not be determined.Historical quality control results indicate that vitros ckmb lot 4932-0216-0281 was not performing as expected in regards to both accuracy and precision at this customer site.Ongoing complaint trending and tracking has not identified any signals of a systemic quality issue associated with vitros ckmb slide lot 4932-0216-0261.Diagnostic within run precision testing was not performed to evaluate the vitros 5600 system performance.Therefore, an unexpected analyzer issue or an issue with vitros ckmb lot 4931-0216-0261 cannot be ruled out as contributing to the event.

Event Description

A customer obtained lower than expected vitros ckmb quality control results when testing vitros isoenzyme performance verifiers on a vitros 5600 integrated system.Vitros isoenzyme performance verifier i lot r5507 vitros ckmb results of 13.2, 15.5 and 16.0 versus the midpoint of the vitros performance verifier i rom 23 u/l.A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The lower than expected vitros ckmb results were obtained when testing a quality control fluid.Ortho has not been made aware of any allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient sample results were not affected during this time or would not be affected if the event were to recur in the future undetected.This report is number two of three mdr¿s for this event.Three 3500a forms are being submitted for this event as three ckmb slide lots were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 7806895
• MDR Text Key: 118398572
• Report Number: 1319809-2018-00106
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: RP
• 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: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 8058232
• Device Lot Number: 4932-0216-0261
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2017
• 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