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

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 08/17/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros crea result was obtained from a single patient sample using vitros crea slides lot 1509-3459-7053 on a vitros 5,1 fs chemistry system.The investigation was unable to determine a definitive assignable cause.No vitros crea slide performance issues are indicated based on the historical crea quality control data.An instrument related event has been ruled out as a contributing factor as vitros within run precision testing was within the acceptable guidelines.Pre-analytical sample processing could not be ruled out as a contributing factor.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The assignable cause is unknown.

Event Description

A customer observed a non-reproducible, lower than expected creatinine result obtained from a single patient sample when using vitros creatinine (crea) slides on a vitros 5,1 fs chemistry system.The magnitude of bias observed exceeded the crea potential health and safety criteria when compared to the expected crea patient result.Vitros crea = 31 umol/l versus expected 262, 258 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The lower than expected crea result was reported outside of the laboratory; however, a physician questioned the result and a corrected report was subsequently issued for the sample after repeat testing.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.Complaint numbers 31981451 / qerts record id 414237.

• 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: 6889468
• MDR Text Key: 89472586
• Report Number: 1319809-2017-00172
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: DA
• 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: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2018
• Device Catalogue Number: 6802584
• Device Lot Number: 1509-3459-7053
• Other Device ID Number: 10758750002849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1