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

Catalog Number 1726926

Device Problem High Test Results (2457)

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

Event Date 09/24/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros amon results were obtained from a non-vitros quality control fluid when processed on two vitros 5600 integrated chemistry systems.A definitive assignable cause could not be confirmed.Historical quality control results indicate a precision issue.There was no definitive evidence to rule out or confirm the vitros 5600 system contributed to the event.In addition, it is unknown how the customer handled the quality control fluids; therefore, an unexpected vitros 5600 system or fluid handling issue could not be ruled out as contributors to the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical support center (tsc) to report higher than expected amon results obtained when processing non-vitros quality control fluids processed on two different vitros 5600 systems.Vitros 5600 system j1, mas lot aa2105m, vitros amon results 336.6 and 286.5 ug/dl versus the expected vitros amon result 238.2 ug/dl.Vitros 5600 system j2, mas lot aa2105m, vitros amon results 281.2 and 327.1 ug/dl versus the expected vitros amon result 232.6 ug/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.The higher than expected vitros amon results were obtained when processing a quality control fluid on two vitros 5600 systems.Ortho was not made aware of any allegation of patient harm as a result of this event.However, the investigation cannot conclude that patient sample results were not affected or would not be affected if the event were to recur undetected.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS AMON 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: 9218715
• MDR Text Key: 214620677
• Report Number: 1319809-2019-00109
• Device Sequence Number: 1
• Product Code: JID
• 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: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 1726926
• Device Lot Number: 1018-0252-8342
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2019
• 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