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

Catalog Number 8298671

Device Problem High Test Results (2457)

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

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros phenytoin (phyt) results were obtained on a patient sample and a quality control (qc) fluid and a higher than expected vitros carbamazepine (crbm) result was obtained from a patient sample when tested using vitros chemistry products phyt slides and vitros chemistry products crbm slides in combination with two different vitros 5600 integrated systems.The most likely assignable cause of the event was a sample related issue.The affected patient correlation samples appeared to be slightly viscous, although no sample metering condition codes were generated when the samples were processed.In addition, some samples may have been stored refrigerated for up to 2 weeks.However, the samples used for the vitros phyt correlation were plasma samples stored refrigerated on average for 7 days, while the vitros crbm correlation were plasma samples stored refrigerated on average for 5 days.Per the vitros phyt instructions for use (ifu), samples can be stored refrigerated for =7 days, while per the vitros crbm ifu, samples can be stored refrigerated for =5 days.Improper sample handling could not be ruled out as contributing to the event as no information was provided concerning the centrifugation procedure or if the samples were centrifuged a second time prior to the retesting events.It is possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.A review of vitros phyt quality control results processed on (b)(4) did show some imprecision within the timeframe of the event.Therefore, an instrument or slide related issue cannot be completely ruled out for the higher than expected vitros phyt results.Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with either vitros phyt reagent lot 2617-0168-2514 or vitros crbm reagent lot 3942-0102-0838.The customer later processed four alternate patient samples and both biorad qc levels on analyzer (b)(4) using both lots of immunowash fluid (iwf) and vitros phyt slides.They also ran an additional four patient samples and both biorad qc levels on analyzer (b)(4) using both lots of iwf and vitros crbm slides.All correlation patient results were deemed acceptable.

Event Description

A customer obtained higher than expected results on patient samples used for correlation testing between a previous and new lot of immunowash fluid (iwf).The patient samples were tested using vitros chemistry products phenytoin (phyt) slides and vitros chemistry products carbamazepine (crbm) slides on two different vitros 5600 integrated systems.A higher than expected quality control fluid result was discovered later.Vitros phyt slide lot 2617-0168-2514 tested on (b)(4).Patient sample a vitros phyt result of 42.8 umol/l vs.The expected result of 29.6 umol/l.Vitros phyt slide lot 2617-0168-2514 tested on (b)(4).Non-vitros biorad immunoassay plus control lot 27730 l3 vitros phyt result of 147.5 umol/l vs.The expected result of 113.0 umol/l.Vitros crbm slide lot 3942-0102-0838 tested on (b)(4).Patient sample q vitros crbm result of 64.8 umol/l vs.The expected result of 44.3 umol/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 vitros phyt and crbm results were not reported outside the lab.There were no allegations of patient harm as a result of this event.This report is number 1 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 8181031
• MDR Text Key: 131911876
• Report Number: 1319809-2018-00166
• Device Sequence Number: 1
• Product Code: DIP
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2617-0168-2514
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2018
• 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