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 03/17/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher than expected vitros ckmb results were obtained from two different patient samples and a single non-vitros quality control fluid processed on the vitros 5600 system.The investigation could not determine a definitive assignable cause, however, it is likely the event was analyzer related, as no recurrence of non-reproducible, higher than expected vitros ckmb results have occurred since service actions were performed on the instrument.Since pre-service precision testing was not performed correctly, an analyzer related event cannot be confirmed.Additionally, since quality control fluid was affected, an unknown reagent related issue cannot be ruled out as contributing to the event.Finally, regarding the patient sample results, pre-analytical sample processing could not be ruled out as a contributing factor as the customer is not adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.A definitive assignable cause for the event could not be determined.

Event Description

The customer obtained non-reproducible, higher than expected vitros ckmb results from two different patient samples and a single non-vitros quality control fluid tested on a vitros 5600 system.Patient sample 1: result of 4.58 ng/ml vs.The expected results of 0.94 and 0.68 ng/ml.Patient sample 2: result of 14.9 ng/ml vs.The expected results of 1.24 and 1.29 ng/ml.Biorad control l1: result of 4.60 ng/ml vs.The expected result of 2.64 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The non-reproducible, higher than expected vitros ckmb patient sample results were reported outside of the laboratory, however, corrected reports were sent to the physician.No treatment was given, changed, or withheld based on the non-reproducible, higher than expected ckmb patient results that were reported.There was no allegation of actual 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.(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: 5595405
• MDR Text Key: 44213505
• Report Number: 3007111389-2016-00063
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 04/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/12/2016
• Device Catalogue Number: 1896836
• Device Lot Number: 1900
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2015
• 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