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 08/24/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros ckmb patient results were obtained using a vitros xt7600 integrated system.The results were high when compared to results obtained from the same sample processed on two non-vitros analyzers (roche cobas8000 and hitachi lobospect).The assignable cause was not determined based on the information provided at this time.There was no information documented regarding the quality control (qc) lot number, qc results or the status of the instrument at the time of comparison testing.Therefore, the performance of the vitros ckmb slide lot and the vitros xt7600 instrument could not be confirmed.However, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ckmb slide lot 4944-0230-2169.Pre-analytical sample handling and storage cannot be ruled out as a potential contributing factor as this information was not documented at the time of this assessment.In addition, there is no clinical information specific to the affected patients documented in the record.Per the vitros ckmb instructions for use limitations of procedure section: ck-bb (present in neonates 12 brain ischemia, cerebellar hematoma, shock 13 and carcinomas 14) and macro ck type i and type ii falsely elevate ck-mb results.These can be differentiated from true ck-mb by the lack of the characteristic ck-mb time pattern.It has been recommended to test the affected samples via electrophoresis to determine if there is any ck-bb or macro ck¿s in the samples that could be causing the higher than expected results.

Event Description

A customer contacted the ortho clinical diagnostics technical solutions center (tsc) because they identified higher than expected ckmb patient results obtained using a vitros xt7600 integrated system.The vitros ckmb results were higher than expected when compared to ckmb results obtained from the same samples processed on two non-vitros analyzers.Sample 1 = 26 versus expected 7, 5 u/l.Sample 2 = 26 versus expected 16 u/l.Sample 3 = 51 versus expected 12, 6 u/l.Sample 4 = 42 versus expected 14 u/l.Sample 5 = 33 versus expected 9, 4 u/l.Sample 6 = 34 versus expected 14, 13 u/l.Sample 7 = 26 versus expected 16 u/l.Sample 9 = 45 versus expected 15, 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 vitros ckmb patient results were not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number 1 of 8 mdr¿s for this event.Eight (8) 3500a forms are being submitted for this event as 8 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 10623527
• MDR Text Key: 249654629
• Report Number: 1319809-2020-00115
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 8058232
• Device Lot Number: 4944-0230-2169
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/02/2020
• Date Device Manufactured: 08/23/2019
• 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