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

Catalog Number 8001133

Device Problem Low Test Results (2458)

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

Event Date 11/01/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ckmb results were obtained from vitros performance verifier quality control fluids run on a vitros 250 chemistry system.User error due to improper vitros qc fluid and ckmb slide cartridge handling were the likely contributing factors to this event.Qc fluid handling & storage was a contributor to this issue as the customer uses the qc fluids until the bottle is empty instead of following the vitros isoenzyme pv instructions for use that states the qc fluid is stable for 5 days when stored at 2-8c.The vitros ckmb assay is sensitive to slide cartridge storage and handling.The customer stores the vtros ckmb slides frozen, load for a calibration event and then refreeze until the slide lot put into use.In addition, once the slide cartridge is placed on the analyzer it is used until cartridge inventory is depleted, which could go beyond 1 week.Per the vitros ckmb instructions for use, the slide cartridge unopened is to be stored frozen.Once opened it is stable for

Event Description

The customer reported lower than expected vitros ckmb results were obtained from vitros performance verifier quality control (qc) fluids run on a vitros 250 chemistry system.Vitros pvi lot f7683 = 9.3, 9.0, 9.6, 10.0, 10.4, 9.2, 9.6, 8.9, 10.2, 9.5, 9.7, 10.3 versus expected 16.7.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 on quality control fluids.There were no reports of erroneous patient results obtained, or reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number: (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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10929780
• MDR Text Key: 219352261
• Report Number: 1319809-2020-00167
• 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: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• 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: 8001133
• Device Lot Number: 4948-0234-5974
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2019
• 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