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

Catalog Number 8298671

Device Problem Low Readings (2460)

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

Event Date 02/08/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined a non-reproducible, lower than expected vitro's phenytoin (phyt) result was obtained for a single patient sample when tested using vitro's chemistry products phyt slides lot 2620-0172-3383 on a vitro's 5600 integrated system.A definitive assignable cause could not be determined.Vitro's phyt within run precision testing using an alternate lot of reagent and diagnostic precision testing using vitro's crbm (carbamazepine) slides were performed by the customer on the vitro's 5600 integrated system.The testing yielded results that were within acceptable guidelines suggesting an instrument issue did not likely contribute to the event.Historical vitro's phyt quality control results indicate acceptable accuracy of vitro's phyt lot 2620-0172-3383, but unacceptable within laboratory precision.The within run phyt precision test suggests the unacceptable within laboratory precision is due to day to day fluid handling inconsistencies.Since the within run vitro's phyt precision test was performed using an alternate lot of vitro's phyt (lot 2620-0172-5478), vitro's phyt lot 2620-0172-3383 cannot be entirely ruled out as a contributor of the event.It is unknown if the customer processed the patient sample following recommendations by the device manufacturer.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this cannot be confirmed.

Event Description

A customer obtained a non-reproducible, lower than expected vitros phenytoin (phyt) result from a single patient sample when tested using vitros chemistry products phyt slides lot 2620-0172-3383 on a vitros 5600 integrated system.Patient sample vitros phyt result of 8.0 ug/ml versus an expected vitros phyt of 34.1 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, lower than expected vitros phyt result was reported from the laboratory.However, no treatment was initiated, altered or stopped based upon the reported result.A corrected report was later issued.Ortho has not been made aware of any allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 9792273
• MDR Text Key: 193072235
• Report Number: 1319809-2020-00031
• 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: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2620-0172-3383
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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