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

Catalog Number 6801756

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

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

Event Date 12/16/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected psa result was obtained from a non-vitros linearity fluid using vitros psa reagent with a vitros 5600 integrated system.A definitive assignable cause could not be established.Precision testing performed was within acceptance limits, confirming the current performance of the vitros 5600 integrated system, however an unexpected instrument issue cannot be completely ruled out as contributing to the lower than expected vitros psa result.Based on historical quality control results, a vitros phyt lot 3291 performance issue is not a likely contributor to the event.The recommended handling protocols and stability characteristics of the non-vitros linearity fluids are not known, therefore inappropriate pre-analytical sample handling cannot be ruled out as a contributing factor.

Event Description

A customer obtained a lower than expected psa result (49.75 ng/ml vs.Expected result of 84.55 ng/ml) from a non-vitros linearity fluid, using vitros psa reagent with a vitros 5600 integrated 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 lower than expected psa result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.(b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS PSA 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: 5513457
• MDR Text Key: 41036970
• Report Number: 3007111389-2016-00050
• Device Sequence Number: 1
• Product Code: LTJ
• 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: 03/21/2016

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: 03/02/2016
• Device Catalogue Number: 6801756
• Device Lot Number: 3291
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2016
• Initial Date FDA Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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