MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES REAGENT PACK; IN-VITRO DIAGNOSTIC

Catalog Number 6802301

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 03/31/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected troponin i es results were obtained from proficiency samples while using a vitros 5600 integrated system.A definitive assignable cause could not be determined.The most likely assignable cause for the lower than expected vitros tropi es cap proficiency sample results is an unknown sample related issue with the cap proficiency samples.There is no indication that the vitros 5600 integrated system or the vitros tropi es reagent malfunctioned in any way.Based on historical quality control results, a vitros tropi es lot 2420 performance issue is not a likely contributor to the event.However, the customer does not process a control fluid with a troponin i concentration at, or below the url.Therefore, the performance of the vitros tropi es reagent lot 2390 at, or below the url concentration of 0.034 ng/ml cannot be determined and a reagent issue could not be entirely ruled out.

Event Description

The customer obtained lower than expected troponin i es results from college of american pathologists (cap) proficiency samples processed on a vitros 5600 integrated system.Cap cr-02 result of 0.02 ng/ml versus the expected result of 0.094 ng/ml.Cap cr-05 result of 0.03 ng/ml versus the expected result of 0.125 ng/ml.The lower than expected vitros tropi es cap proficiency fluid results were from non-patient fluids and were reported to the proficiency provider by the customer.Biased results of the direction and magnitude observed could lead to inappropriate physician action if occurred undetected with patient samples.There was no report of affected patient samples, however; the investigation cannot rule out that patient sample results were affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TROPONIN I ES 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: 6604314
• MDR Text Key: 77010215
• Report Number: 3007111389-2017-00071
• Device Sequence Number: 1
• Product Code: MMI
• 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: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/10/2017
• Device Catalogue Number: 6802301
• Device Lot Number: 2420
• Other Device ID Number: 10758750002504
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2016
• 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