MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 1896836

Device Problem High Test Results (2457)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/11/2014

Event Type  malfunction  

Event Description

An ocd laboratory specialist observed a single non-reproducible, higher than expected vitros ckmb result from a non-vitros qc sample processed on a vitros 5600 integrated system.Non-vitros qc sample level 1: vitros ck-mb result of 4.508 ng/ml vs.Vitros assigned mean of 3.37 ng/ml.Biased result of the direction and magnitude observed may lead to inappropriate physician action if undetected.No patient samples were affected and there were no allegations of harm as a result of the events described.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.This report corresponds to ortho clinical diagnostics inc.(b)(4).

Manufacturer Narrative

The investigation confirmed that a non-reproducible, higher than expected vitros ckmb result was obtained from a non-vitros qc sample processed on a vitros 5600 system.Root cause of the higher than expected qc test result could not be determined, although the investigation could not exclude inappropriate pre-analytical sample handling / storage of the test materials as a possible root cause.The investigation also could not exclude unexpected vitros analyzer or ck-mb product performance as possible contributory factors.

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT CKMB 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: 4398763
• MDR Text Key: 5434268
• Report Number: 3007111389-2015-00007
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/08/2015

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: 03/03/2015
• Device Catalogue Number: 1896836
• Device Lot Number: 1690
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/11/2014
• Initial Date FDA Received: 01/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1