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

Catalog Number 6802584

Device Problems Incorrect Or Inadequate Test Results (2456); Low Test Results (2458)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that reproducible lower than expected vitros crea results were obtained from multiple samples from a single patient using vitros crea slide lots on two vitros 4600 chemistry systems.The investigation was unable to determine a definitive assignable cause.However, since the issue was isolated to samples collected from a single patient, an unknown sample interferent that affects the vitros assay, but not the non-vitros assays, is the likely cause of the event, but this could not be confirmed.Based on the issue occurring on two separate vitros instruments, it is unlikely an instrument related issue contributed to the event.The historical quality control data review indicates the vitros crea slides did not likely contribute to the event.

Event Description

A customer obtained reproducible, lower than expected vitros crea results from multiple samples collected from a single patient tested on two different 4600 chemistry systems when compared to multiple non-vitros methods.The (b)(6) sample crea result of 132 umol/l vs.The expected result of 290 umol/l.The (b)(6) sample crea result of 116 umol/l vs.The expected result of 241 umol/l.The (b)(6) sample crea result of 103 umol/l vs.The expected result of 213 umol/l.The (b)(6) sample crea result of 95 umol/l vs.The expected result of 188 umol/l.The (b)(6) sample crea result of 94 umol/l vs.The expected result of 184 umol/l.The (b)(6) sample crea result of 103 umol/l vs.The expected result of 195 umol/l.The vitros crea results were not reported outside of the laboratory and there was no allegation of patient harm as a result of the 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: 6500982
• MDR Text Key: 73238451
• Report Number: 1319809-2017-00041
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 04/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 6802584
• Device Lot Number: 1505-3449-1401
• Other Device ID Number: 10758750002849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2016
• 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