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 10/24/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros psa quality control result from a non-vitros quality control fluid run on a vitros eci immunodiagnostic system.The assignable cause of the lower than expected result could not be determined, however an unidentified instrument issue is suspected to be a contributing factor.A reagent issue could not be entirely ruled out as a potential contributing factor.

Event Description

A lower than expected vitros psa quality control result was obtained from a non-vitros quality control fluid run on a vitros eci immunodiagnostic system.Vitros psa result = 1.405 ng/ml vs.Expected result = 2.2 ng/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action.No patient samples were processed over the time frame of the event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this 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: 5244031
• MDR Text Key: 32202087
• Report Number: 3007111389-2015-00377
• 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: 11/23/2015

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: 02/03/2016
• Device Catalogue Number: 6801756
• Device Lot Number: 3280
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2015
• Initial Date FDA Received: 11/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2015
• 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