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

Catalog Number 1896836

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

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

Event Date 06/19/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher than expected vitros ckmb results were obtained from a quality control fluid processed on the vitros eci immunodiagnostic system.The investigation could not determine a definitive assignable cause with the information provided.Results from precision testing of the customer¿s vitros eci immunodiagnostic system prior to and following service actions by an ortho field engineer indicate that the instrument was operating as expected.There was no indication that an instrument performance issue contributed to the event.Historical qc data shows no evidence of a reagent performance issue, however, since quality control fluid was affected, an unexpected reagent related issue cannot be entirely ruled out as contributing to the event.Finally, inappropriate pre-analytical sample handling could not be entirely ruled out as contributing to the higher than expected ckmb results as sufficient information was not provided to determine whether the customer was following an appropriate fluid handling protocol.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 quality control fluid tested on a vitros eci immunodiagnostic system.Level 1 qc: 8.45, 6.95, 7.12, 5.69, 6.96, 6.48 and 6.52 ng/ml versus expected result of 3.27 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The non-reproducible, higher than expected vitros ckmb quality control fluid results were not reported outside of the laboratory.No evidence was provided by the customer to suggest that patient results were affected, however the investigation cannot conclude that patient results would not to be affected if the event were to recur undetected.There is no allegation of actual patient harm as a result of this event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTICS PRODUCT CKMB REAGENT
• 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: 5811269
• MDR Text Key: 50919704
• Report Number: 3007111389-2016-00126
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2016
• 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?: No
• Date Manufacturer Received: 06/27/2016
• 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