MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK IN VITRO DIAGNOSTIC

Catalog Number 1896836

Device Problem Low Test Results (2458)

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

Event Date 09/05/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation has determined that a non-reproducible, lower than expected vitros tropi es result and a vitros ckmb result were obtained from a patient sample using the vitros 5600 integrated system. A definitive root cause could not be determined. Based on acceptable performance of historical tropi es and ckmb quality control data, a reagent issue was ruled out as a potential contributing factor. An instrument related event has been ruled out as a contributing factor as within run precision testing was within the acceptable guidelines. Pre-analytical sample processing could not be ruled out as a contributing factor, as it is unknown if the customer is adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation. It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.

Event Description

A customer obtained non-reproducible, lower than expected troponin i and ckmb results from a patient sample using vitros troponin i es (tropi) reagent and vitros ckmb reagent on a vitros 5600 integrated system. Patient sample results: vitros tropi es result <0. 012 ng/ml versus expected vitros tropi es result 1. 88 ng/ml. Vitros ckmb result 0. 25 ng/ml versus expected vitros ckmb result 19. 6 ng/ml. A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected. The higher than expected results were not reported from the laboratory and there was no allegation patient harm. 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. Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS CK-MB REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6919005
• MDR Text Key: 89941394
• Report Number: 3007111389-2017-00154
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 10/05/2017

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/09/2018
• Device Catalogue Number: 1896836
• Device Lot Number: 2150
• Other Device ID Number: 10758750000203
• 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: 09/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage