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

Catalog Number 8001133

Device Problem High Test Results (2457)

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

Event Date 06/05/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that repeatable elevated vitros ckmb results were obtained from two samples collected from the same patient using vitros ckmb slides on a vitros 5600 integrated system.The elevated vitros ckmb results are most likely due to the presence of a macro ck type i or type ii interferent as described in the vitros ckmb ifu.The customer sent one of the patient samples for testing on an alternate vidas biomerieux method, which produced a result in the negative range.The customer also did not test a second sample within the 18 hour recommendation listed in the ifu, however there was no significant fall in activity in the second sample collected approximately two and a half weeks after the initial sample, indicating that the elevated ckmb is most likely due to the presence of macro ck type i or type ii as described in the ifu.Historical quality control results for vitros ckmb are within expectation, indicating that an issue with the vitros ckmb slides is not likely.Additionally, a vitros alkp diagnostic precision was within ortho acceptable guidelines, indicating that the vitros 5600 integrated system was performing as expected.Although the precision was not run at the time that the initial results were produced, it was run on the same day that the samples were repeated and gave similar results to the original, indicating that the instrument performance had not likely changed between the time of the initial and repeat runs.(b)(4).

Event Description

The investigation determined that repeatable elevated vitros ckmb results were obtained from two samples collected from the same patient using vitros ckmb slides on a vitros 5600 integrated system.Vitros ckmb patient results of 266, 267, 267, 210, and 225 (positive) versus the expected result of negative.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The elevated vitros ckmb results were not reported by the laboratory.There was no allegation of patient harm as a result of this event.This report is number two 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 CKMB SLIDES
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12135471
• MDR Text Key: 281743312
• Report Number: 1319809-2021-00115
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 07/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 8001133
• Device Lot Number: 4947-0241-5853
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1