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

Catalog Number 8298671

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/04/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation concluded that lower than expected vitros chemistry products phenytoin (phyt) results were obtained from a college of american pathologists (cap) proficiency sample and from vitros tdm pv fluid using vitros phyt slides in combination with a vitros 5600 integrated system.There were two events discovered during the investigation.Event #1: (b)(6) 2018.Vitros phyt slide lot 2617-0167-1476.Proficiency sample chm-13 vitros phyt result of less than 3.0 versus expected vitros peer mean of 5.69 ug/ml.The assignable cause of this event is user error due to an inappropriate interpretation of an analyzer condition code.The vitros 5600 integrated system did not generate a vitros phyt result of less than 3.0 ug/ml for the sample, which was the value reported by the customer.An analyzer condition code occurred when the sample was initially run, and no vitros phyt result was generated at that time.The condition code text states to dilute for a result higher than the measuring range.The customer retested cap sample chm-13 with a 2x dilution, and generated a result of less than 6.0 ug/ml.The customer did not report the vitros phyt result of less than 6.0 ug/ml, but reported less than 3.0 ug/ml, as they realized the vitros instrument had multiplied a phyt value of less than 3.0 ug/ml by the dilution factor of 2.Since the phenytoin concentration of cap sample chm-13 was not above the vitros phyt measuring range of 3.0 ¿ 40 ug/ml, it was not appropriate to dilute the sample.Event #2: (b)(6) 2018 and (b)(6) 2019.Vitros phyt slide, lot 2617-0168-4312.Vitros tdm pv e6508 results of 20.73 and 14.84 ug/ml, vs.The baseline mean result of 26.27 ug/ml.The assignable cause of this event is unknown.The customer stated that during the timeframe of the event, multiple quality control lots were stored in the freezer and refrigerator after opening without regard to open vial stability limits and without separation of lot numbers.It is possible that unsuitable fluids were used or a pre-analytical sample mixup occurred, although this could not be confirmed.A vitros phyt within-run precision test with results within acceptable limits was performed approximately 2 months after the events occurred.This precision test indicated vitros phyt slide lot 2617-0168-4312 was currently performing as intended on the vitros 5600 system.However, it is unknown how the vitros phyt slides were performing on the vitros 5600 system at the time the events occurred.Therefore, an instrument or vitros phyt assay issue cannot be completely ruled out as contributing to the event.Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt lot 2617-0168-4312.No vitros phyt patient results were questioned.There was no allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient samples would not be affected if the event were to recur undetected.Ongoing tracking and trending of complaints has not identified any signals that would suggest there is a systemic issue with vitros phyt lot 2617-0168-4312.

Event Description

A complaint was received reporting lower than expected vitros phenytoin (phyt) results from a college of american pathologists (cap) proficiency sample and vitros therapeutic drug monitoring performance verifiers (tdm pv¿s) using vitros chemistry products phenytoin slides on a vitros 5600 integrated system.Cap proficiency sample chm-13 vitros phyt result of less than 3.0 ug/ml versus the expected result of 5.69 ug/ml vitros tdm pv e6508 results of 20.73 and 14.84 ug/ml, vs.The baseline mean result of 26.27 ug/ml.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 phyt results were obtained when processing cap and vitros quality control fluids with no patient results being questioned.The investigation could not rule out that patient results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of this event.This report is number 2 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: 8474527
• MDR Text Key: 148633524
• Report Number: 1319809-2019-00023
• Device Sequence Number: 1
• Product Code: DIP
• 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: 04/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2617-0168-4312
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2018
• 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