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

Catalog Number 1707801

Device Problem High Test Results (2457)

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

Event Date 05/02/2014

Event Type  malfunction  

Event Description

The customer obtained a non-reproducible, higher than expected glucose result from a patient sample (patient= >625 vs.Expected 85 mg/dl) processed on a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected glucose result was not reported from the laboratory.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected glucose result was obtained from a patient sample while using the vitros 5600 integrated system.There was no indication that an instrument issue contributed to the event.The investigation determined the sample was not processed in accordance with the tube manufacturer¿s recommendations.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The investigation could not determine a definitive root cause.However, a pre-analytical sample handling issue and a reagent issue cannot be ruled out as potential contributing factors.

• Brand Name: VITROS CHEMISTRY PRODUCTS GLU SLIDES
• Type of Device: IN VITRO DIAGNOSTICS
• 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: 3846115
• MDR Text Key: 4407070
• Report Number: 1319809-2014-00024
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 06/03/2014

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: 06/01/2015
• Device Catalogue Number: 1707801
• Device Lot Number: 0006-0867-8954
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 06/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2013
• 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