MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CA SLIDES; IN VITRO DIAGNOSTIC

Catalog Number 1450261

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

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

Event Date 12/22/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros ca results were obtained from a single linearity sample samples using two vitros ca slide lots on a vitros 350 chemistry system.The investigation concluded that the most likely cause of the lower than expected vitros ca results was related to an unknown cap linearity sample issue.Although vitros 350 system performance tests were not performed, there was no evidence to suggest the vitros 350 system malfunctioned.Historical vitros ca quality control results exhibited acceptable performance of vitros ca slide lots 0332-0532-1134 and 0337-0538-6119.There was no evidence to suggest the reagent malfunctioned.

Event Description

A customer obtained lower than expected vitros ca results from testing a (b)(6) ln2bv-b 2016 chemistry/lipid/enzyme calibration verification/linearity fluid when compared to the peer mean using a vitros 350 chemistry system.Sample (b)(6) vitros ca result 9.15* and 9.4* mg/dl versus peer mean 12.08 mg/dl.The investigation cannot rule out or confirm that patient results could not be similarly affected.The affected results were not reported out of the laboratory.There was no report of patient harm as a result of this event.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 CHEMISTRY PRODUCTS CA SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6428809
• MDR Text Key: 71104924
• Report Number: 1319809-2017-00027
• Device Sequence Number: 1
• Product Code: CJY
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 1450261
• Device Lot Number: 0337-0538-6119
• Other Device ID Number: 10758750009114
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2016
• 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