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

Catalog Number 6802584

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected creatinine result was obtained from a patient sample processed using vitros crea slides with a vitros 5, 1fs chemistry system.A definitive assignable cause could not be determined.There is no indication of a systemic crea reagent issue.The issue was isolated to a single event.Historic vitros crea quality control data was reviewed and concluded to be performing within expectations.A within run precision test was processed and results were within acceptable guidelines indicating the instrument was performing as expected.An instrument related issue can be ruled out as a contributing factor.Pre-analytical sample processing could not be ruled out as a contributing factor, as it is not known if the customer is not adhering to the sample collection device manufacturer's recommendations for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer obtained a higher than expected creatinine result from a patient sample processed using vitros crea slides in combination with a vitros 5,1fs chemistry system.Patient result of 4.43 mg/dl versus the expected result of 0.73 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros crea result was reported from the laboratory, however, sample testing was repeated and a corrected report was issued for the affected sample.There were no allegations of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA 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: 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7390416
• MDR Text Key: 104538034
• Report Number: 1319809-2018-00058
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1513-3471-4802
• Other Device ID Number: 10758750002849
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• 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