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

Catalog Number 8379034

Device Problem Incorrect Or Inadequate Test Results (2456)

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

Event Date 07/26/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected sodium (na+) results were obtained from a non-vitros biorad quality control fluid (lot 47943) processed using vitros na+ microslides on a vitros 350 chemistry system.The assignable cause could not be determined.The customer did not provide historical quality control results for assessment of na+ performance prior to the day of the event.Therefore, a reagent issue cannot be ruled out as a contributing factor.In addition, user error where the customer used an inappropriate reference fluid lot cannot be ruled out as a potential contributing factor.Performance testing indicates that the vitros 350 chemistry system was performing as intended and an instrument was ruled out as a contributing factor.

Event Description

The investigation determined that lower than expected sodium (na+) results were obtained from a non-vitros biorad lot 47943 quality control fluid processed using vitros na+ microslides on a vitros 350 chemistry system.Biorad lot 47943 = 135, 135, 135, 136, 132 mmol/l versus expected 173 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 unexpected vitros na+ results were generated from non-patient fluids, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report is number 1 of 5 mdr¿s for this event.Five (5) 3500a forms are being submitted for this event as 5 devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS NA+ 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: 6813510
• MDR Text Key: 83747305
• Report Number: 1319809-2017-00156
• Device Sequence Number: 1
• Product Code: JGS
• 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: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2018
• Device Catalogue Number: 8379034
• Device Lot Number: 4208-0969-1154
• Other Device ID Number: 10758750004812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1