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

Catalog Number 1707801

Device Problem Low Test Results (2458)

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

Event Date 08/15/2014

Event Type  malfunction  

Event Description

The customer obtained a non-reproducible, lower than expected vitros glu result for one patient sample run on a vitros 5600 chemistry system.Patient sample = 3.2 mmol/l versus expected 11.4 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.The affected results were reported outside the laboratory; however, a corrected report was issued once repeat testing was complete.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.(b)(4).

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros glu result was obtained for one patient sample run on a vitros 5600 chemistry system.The investigation was unable to determine a definitive root cause.The investigation determined that the vitros 5600 chemistry system was operating as expected at the time of the event.There was no evidence of a vitros glu reagent malfunction based on review of recent quality control data.Pre-analytical sample handling and an (b)(6) lab automation routing issue were ruled out as contributing factors.Outside of the one patient sample in question, no further issues have been noted with vitros glu performance at this customer site.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU 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: 4090270
• MDR Text Key: 4746130
• Report Number: 1319809-2014-00048
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/15/2014

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: 12/01/2015
• Device Catalogue Number: 1707801
• Device Lot Number: 0010-0880-4764
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/18/2014
• Initial Date FDA Received: 09/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2014
• 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