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

Catalog Number 8001133

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that lower than expected vitros ck-mb results were obtained from vitros isoenzyme performance verifiers and lower than expected vitros bu results were obtained from vitros performance verifiers processed using vitros chemistry products ck-mb slides and vitros chemistry products bubc slides on a vitros 250 chemistry system.Based on the limited information provided, the assignable cause of the lower than expected vitros ck-mb and vitros bu quality control results is improper protocol related to the preparation of the vitros calibrators and vitros control fluids.After an operator prepared vitros calibrators and vitros control fluids and processed them on the vitros 250 system, qc results were lower than expected for vitros ck-mb and vitros bu.An alternate operator then prepared fresh vials of vitros calibrators and vitros control fluids and processed them on the vitros 250 system.Qc results for both vitros ck-mb and vitros bu returned to expectations.No historical qc results were provided; however, a reagent issue is not likely a contributor of the event as expected qc results were obtained after fresh vials of vitros calibrators and vitros control fluids were prepared and processed by an alternate operator.Although precision testing was not performed on the vitros 250 chemistry system an instrument related issue is not a likely contributor of the event as qc results returned to within expectations after recalibration events without any known troubleshooting actions being performed on the instrument.Continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ck-mb lot 4903-0239-4310 or vitros bubc lot 0246-0428-5626.Email address for contact office above is: (b)(6).

Event Description

The investigation has determined that lower than expected vitros ck-mb results were obtained from vitros isoenzyme performance verifiers and lower than expected vitros bubc results were obtained from vitros performance verifiers processed using vitros chemistry products ck-mb slides and vitros chemistry products bubc slides on a vitros 250 chemistry system.The magnitude of bias of the vitros ck-mb and vitros bu results meets potential health and safety criteria and the results are reportable.Vitros ipv i lot h8087 vitros ck-mb results of 0.7 and 0.7 u/l vs an expected result of 19 u/l vitros pv ii lot l7425 vitros bu result of 0.07 mg/dl vs an expected result of 8.85 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected results were obtained from quality control fluids and no results were reported from the laboratory.No patient sample results were affected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CK-MB 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11898016
• MDR Text Key: 266942079
• Report Number: 1319809-2021-00094
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 8001133
• Device Lot Number: 4903-0239-4310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2020
• 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