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

Catalog Number 8001133

Device Problem Incorrect, Inadequate or Imprecise Resultor Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/21/2016

Event Type  malfunction  

Manufacturer Narrative

The assignable cause of the event is a known limitation of the vitros ckmb slide assay. The results of the non-vitros fractionation indicate that 34% of the total ck enzyme in the sample consists of the macro type i isoenzyme. Per the vitros ckmb slide assay instruction for use (ifu), macro ck type i and type ii can cause falsely elevated vitros ckmb results. There was no indication the vitros ckmb microslide reagent or the vitros 5600 instrument malfunctioned.

Event Description

The customer reported higher than expected vitros ckmb results were obtained from a single patient sample using two different lots of vitros ckmb slides on a vitros 5600 analyzer, when compared to a non-vitros fractionation method. Biased results of the direction and magnitude observed may lead to inappropriate physician action. Vitros ckmb slide lot 4935-0202-5258. Patient sample result of 104 u/l vs. The expected result of <16 u/l. Vitros ckmb slide lot 4935-0202-6522. Patient sample result of 104 u/l vs. The expected result of <16 u/l. The higher than expected results were not reported outside of the laboratory. There was no report of patient harm as a result of this event. This report is number 1 of 2 mdr's for this event. Two (2) 3500a forms are being submitted for this event as 2 devices were involved. (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CKMB SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 5484888
• MDR Text Key: 40032544
• Report Number: 1319809-2016-00032
• Device Sequence Number: 1
• Product Code: JHS
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o

Reporter Occupation

• Type of Report: Initial
• Report Date: 03/07/2016

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 01/01/2017
• Device Catalogue Number: 8001133
• Device Lot Number: 4935-0202-5258
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/12/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse