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

Catalog Number 1896836

Device Problem High Test Results (2457)

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

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected ck-mb result was obtained from a single patient sample using vitros ck-mb reagent with a vitros eci immunodiagnostic system.The definitive assignable cause could not be determined.An instrument issue could not be ruled out as contributing to the event as an assessment of the system has yet to be performed.Historical quality control data was not provided and therefore a vitros ck-mb lot 1850 performance issue could also not be ruled out as a contributing factor.Ortho determined that the customer was not following the sample collection device manufacturer¿s recommendations for sample centrifugation, so pre-analytical sample handling could not be ruled out as contributing to the event.It is likely 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 a non-reproducible, higher than expected creatine kinase-mb (ck-mb) result from a single patient sample (ck-mb = 3.32 ng/ml vs.Expected result of 2.04 ng/ml) using vitros ck-mb reagent with a vitros eci immunodiagnostic system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected ck-mb result was reported from the laboratory, however, there was no allegation of patient harm as a result of the event.(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: 5379349
• MDR Text Key: 36955856
• Report Number: 3007111389-2016-00008
• Device Sequence Number: 1
• Product Code: JHX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2016
• Device Catalogue Number: 1896836
• Device Lot Number: 1850
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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