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

Catalog Number 6802584

Device Problem Low Test Results (2458)

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

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros crea results were obtained during a patient sample correlation and when processing one patient sample using two vitros 250 chemistry systems when compared to results obtained from a non-vitros labtest method.(units mg/dl) the ortho ls stated that similar results were obtained on a second vitros 250 chemistry system (s/n (b)(4)) during the patient sample correlation study, however no results were provided.The ortho ls also stated the vitros crea results do not correlate with the urea result for each patient, however the results were not provided for review.There are no details provided regarding the patient diagnosis or medication list for the patients included in the correlation study.Although vitros crea quality control results were acceptable on the day of testing, historical vitros crea lot 1523-3494-1933 quality control results were not provided.Therefore, a vitros crea reagent issue or an instrument issue cannot be ruled out as potential contributors to this event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea slide lot 1523-3494-1933.

Event Description

An ortho laboratory specialist (ls) contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) on behalf of the customer to report lower than expected vitros chemistry products creatinine (crea) patient results obtained during a correlation study and when processing one patient sample when compared to results obtained from the non-vitros labtest method using two vitros 250 chemistry systems.Sample 1, vitros crea result 0.5 mg/dl versus the labtest crea result 2.9 mg/dl.Sample 2, vitros crea result 0.9 mg/dl versus the labtest crea result 2.0 mg/dl.Sample 3, vitros crea result 0.6 mg/dl versus the labtest crea result 3.1 mg/dl.Sample 4, vitros crea result 0.8 mg/dl versus the labtest crea result 1.9 mg/dl.Sample 5, vitros crea result 1.0 mg/dl versus the labtest crea result 1.8 mg/dl.Sample 10, vitros crea result 0.7 mg/dl versus the labtest crea result 1.70 mg/dl.Repeat testing of samples using vitros crea slides on a second vitros 250 chemistry system (sn: (b)(4)) produced the same lower than expected results.However, the results were not provided.Patient sample, vitros crea result 0.3 mg/dl versus the labtest crea result 3.0 mg/dl and orion result 5.0.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The vitros crea results obtained during the correlation study were not reported to the physician.The vitros crea result obtained from the patient sample was reported outside of the laboratory, however ortho was not made aware of any allegation of patient harm.This report is number 4 of 13 mdr¿s for this event.Thirteen (13) 3500a forms are being submitted for this event as 13 devices were involved.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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9722883
• MDR Text Key: 205337717
• Report Number: 1319809-2020-00017
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1523-3494-1933
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/14/2019
• 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