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

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 11/19/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros psa results were obtained from three separate patient samples on a vitros 5600 integrated system.A definitive root cause could not be confirmed.The investigation cannot rule out the vitros psa reagent or the vitros 5600 integrated system as contributing factors, but there is no evidence that they were not performing as intended.In addition, improper pre-analytical handling cannot be ruled out as a potentially contributing factor.

Event Description

A customer obtained lower than expected vitros psa results from two separate patient samples on a vitros 5600 integrated system.Patient sample 1 result = <0.064 ng/ml vs.Expected result = 0.711 ng/ml.Patient sample 2 result = 0.084 ng/ml vs.Expected result = 0.654 ng/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The lower than expected patient results were reported from the laboratory, however treatment was not altered, initiated, or stopped based upon the reported results.There were no allegations of patient harm.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 PSA REAGENT PACK
• Type of Device: IN-VITRO
• 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: 5318933
• MDR Text Key: 34925356
• Report Number: 3007111389-2015-00403
• 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: Other
• Type of Report: Initial
• Report Date: 12/22/2015

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?: No
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/22/2015
• 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