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

Catalog Number 8379034

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/10/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible, higher than expected vitros sodium (na+) results were obtained from a non-vitros biorad quality control (qc) fluid processed using vitros chemistry products na+ slides lot 4232-1043-4495 on a vitros 5600 integrated system.The investigation could not determine a definitive assignable cause of the event.Based on historical quality control results, a vitros na+ lot 4232-1043-4495 performance issue is not a likely contributor to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4232-1043-4495.A slide cartridge related issue could not be confirmed nor entirely ruled out as contributor of the event.However, it is not a likely cause as the non-reproducible, higher than expected results were obtained from two different slide cartridges.In addition, acceptable results were obtained upon repeat testing from the same slide cartridge in each event.An instrument related issue is not a likely contributor of the event as diagnostic precision testing performed on the vitros 5600 integrated system was within ortho acceptable guidelines.(b)(4).

Event Description

The investigation determined that non-reproducible, higher than expected vitros sodium (na+) results were obtained from a non-vitros biorad quality control (qc) fluid processed using vitros chemistry products na+ slides lot 4232-1043-4495 on a vitros 5600 integrated system.Biorad lot 56950 level 1 results of >250 and >250 mmol/l vs an expected result of 121.6 mmol/l biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The non-reproducible, higher than expected results were from a qc fluid and were not reported outside of the laboratory.However, the investigation was unable to confirm that patient sample results were not or would not be affected if the event were to recur undetected.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report is number one 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 (ortho) complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 11753005
• MDR Text Key: 280546210
• Report Number: 1319809-2021-00070
• Device Sequence Number: 1
• Product Code: JGS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Catalogue Number: 8379034
• Device Lot Number: 4232-1043-4495
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1