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

Catalog Number 6802584

Device Problem High Test Results (2457)

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

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected crea result was obtained from the non vitros mas qc fluid lot r1908 level when compared to qc package insert (pi) value.Although a definitive assignable cause was not identified, an unknown sample contaminant, specific to that cup/fluid event, is the likely assignable cause as the issue was specific to a single cup.In addition, pre analytical sample mix up cannot be ruled out as a contributing factor to the event.There was no indication that the vitros 5600 integrated system, or the vitros reagent lot in use malfunctioned.

Event Description

The customer observed a higher than expected creatinine (crea) result from a non-vitros quality control (qc) fluid processed using a vitros 5600 integrated chemistry system.Thermo fisher mas qc fluid, level 1, lot r1908 result 262 umol/l versus the expected pack insert mean 86.6 umol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected.There was no allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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: 6767015
• MDR Text Key: 83170064
• Report Number: 1319809-2017-00139
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 08/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2018
• Device Catalogue Number: 6802584
• Device Lot Number: 1507-3461-9180
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/05/2016
• 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