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 06/15/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, lower than expected vitros tsh and crea results were obtained from a single patient sample when tested on a vitros 5600 integrated system.The assignable cause could not be determined.Pre-analytical sample handling related to improper centrifugation could not be ruled out as contributing factors to the lower than expected patient result.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.Since multiple assays were affected and the tsh and crea daily quality control testing is within expectations, the tsh reagent and crea slide lot performance did not likely contribute to the event successful within run precision testing using multiple assays indicates the instrument is performing as intended.A systemic instrument issue can be ruled out as a contributing factor.Although, a transient instrument issue cannot be completely ruled out as a contributing factor.The lower than expected tsh and crea patient results were reported outside of the laboratory.A corrected report was later issued.There was no allegation of patient harm as a result of this event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issues with vitros immunodiagnostic products tsh reagent pack, lot 5655 or with vitros chemistry products crea slides lot 1515-3478-8908.

Event Description

A customer obtained non-reproducible, lower than expected vitros tsh and crea results when processing a single patient sample on a vitros 5600 integrated system.Patient sample 1, vitros tsh result 0.396 miu/l versus the expected vitros tsh result 0.648 miu/l.Patient sample 1, vitros crea result 0.96 mg/dl versus the expected vitros crea result 1.64 mg/dl.A biased result of the direction and magnitude observed may lead to inappropriate medical action if not detected.The lower than expected tsh and crea patient results were reported outside of the laboratory.A corrected report was later issued.There was no allegation of patient harm as a result of this event.This report is number two of two mdr's for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc.(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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7707625
• MDR Text Key: 115674936
• Report Number: 1319809-2018-00098
• 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: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-3478-8908
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1