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

Catalog Number 8298671

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that non-reproducible vitros phyt results were obtained from a single patient sample tested on a vitros 5600 integrated system.The investigation was unable to determine a definitive assignable cause for this event.A sample matrix issue related to the affected patient cannot be ruled out.The issue is isolated only to the single affected patient sample, as other patient samples run over this time frame did not demonstrate a similar issue.Quality control and precision test results from the time frame of the event demonstrated acceptable within-laboratory and within-run performance of the vitros phyt slide lot 2619-0171-2451.With the exception of the non-reproducible results obtained from the affected patient sample, vitros phyt lot 2619-0171-2451 otherwise appeared to be performing within expectations.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros phyt lot 2619-0171-2451.In addition, results of precision tests were within acceptable guidelines.The vitros 5600 integrated system was operating as expected at the time of the event.Finally, the affected sample was not centrifuged according to the collection device manufacturer¿s recommendations.Therefore, improper pre-analytical sample handling cannot be ruled out as a contributing factor.It is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report non-reproducible vitros phyt results were obtained from the same patient sample.Patient sample results of 87 and 92 umol/l vs.The expected result of 135 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 unexpected, non-reproducible results for the patient sample were not reported outside of the laboratory.There was no reported allegation of patient harm as a result of this event.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: 9495313
• MDR Text Key: 214629364
• Report Number: 1319809-2019-00123
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: 8298671
• Device Lot Number: 2619-0171-2451
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• 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