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

Catalog Number 8298671

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 03/22/2021

Event Type  malfunction  

Manufacturer Narrative

The customer obtained unexpected vitros phyt results for cap proficiency sample chm-01 using vitros phyt slide lot 2621-0175-3890 on a vitros 5600 integrated system.The assignable cause of this event is user error due to inappropriate interpretation of an analyzer condition code.An analyzer condition code u90-382 (ir wash error) occurred when the sample was initially run, and no phyt result was generated at that time.The condition code instructed the operator to program the sample for repeat phyt testing with dilution to confirm if the result is greater than the assay measuring range.The laboratory performed 5x dilution of the cap sample and the result obtained was less than the phyt measuring range (3.0 ug/ml) multiplied by the 5x dilution factor (<15.0 ug/ml).However, the lab reported a phyt result equal to the low end of the phyt measuring range (<3.0 ug/ml) as they removed the dilution factor.It was not appropriate for the user to report the phyt result obtained from the dilution because the phyt concentration in that sample did not exceed the measuring range.A review of historical qc performance for vitros phyt lot 2621-0175-3890 concluded that phyt was performing as expected.A diagnostic precision test was within ortho acceptable guidelines indicating the vitros 5600 integrated was performing as expected at the time the precision was run.Therefore, there is no indication that an issue with the phyt slide lot or the vitros 5600 system had contributed to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with this vitros phyt slide lot 2621-0175-3890.Email address for contact office is (b)(4).

Event Description

The customer obtained unexpected vitros chemistry products phenytoin (phyt) result for a college of american pathologists (cap) proficiency sample, using vitros phyt slide lot 2621-0175-3890 on a vitros 5600 integrated system.Cap chm-01 phyt result <3.0, <15.0 (5x dilution) versus expected vitros peer mean of 5.08 ug/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.There was no report that patient results were affected.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT 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 ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 11876900
• MDR Text Key: 263525221
• Report Number: 1319809-2021-00093
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• 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: 05/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Catalogue Number: 8298671
• Device Lot Number: 2621-0175-3890
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2020
• 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