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

Catalog Number 6802584

Device Problem Low Readings (2460)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros crea result was obtained from a quality control (qc) fluid processed using vitros chemistry products creatinine (crea) slides lot 1531-3500-7910 in combination with a vitros 5600 integrated system.A definitive assignable cause of the lower than expected vitros crea result could not be determined.No information was provided by the customer from the time period of the event.Historical vitros qc information was obtained from e-connectivity, however the customer did not provide any baseline qc information or details regarding the qc fluid in use for vitros crea.A reagent issue is not a likely contributor of the event as the customer was able to obtain an acceptable result for the l2 vitros crea qc fluid using the same cartridge of vitros crea.In addition, continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros crea lot 1531-3500-7910.Although a within run precision test was not performed, an analyzer issue is not a likely cause of the event as the customer was able to obtain acceptable results at the time of the event without any actions performed on the analyzer.The customer did not provide their fluid handling protocol, therefore, a fluid handling issue cannot be ruled out as a potential cause of the event.Email address for contact office bove is (b)(4).

Event Description

A customer reported a lower than expected vitros crea result obtained from a quality control fluid processed using vitros chemistry products creatinine (crea) slides in combination with a vitros 5600 integrated system.Unknown l2 qc fluid lot 1446un vitros crea result 1.39 mg/dl versus expected vitros crea result 1.77 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The lower than expected vitros crea result was obtained when processing a quality control fluid and was not reported from the laboratory.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.There has been no allegation 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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11246012
• MDR Text Key: 245792893
• Report Number: 1319809-2021-00002
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1531-3500-7910
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2020
• 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