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 08/09/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected amon results were obtained from non-vitros biorad lot 54140 quality control fluids processed using vitros amon slides with a vitros 5600 integrated system.The assignable cause is user error, associated with calibration.The customer calibrated the vitros amon slides using calibrator kit 1, when the valid calibrator kit for the vitros amon assay is calibrator kit 5.Acceptable vitros amon performance was obtained after restoring a previous calibration generated using calibrator kit 5.

Event Description

A customer obtained higher than expected ammonia (amon) results from non-vitros biorad lot 54140 quality control fluids (level 1= >500, >500, >500 versus expected 25.23 umol/l; level 3= >500, >500 versus expected 231.8 umol/l) using vitros amon slides in combination with a vitros 5600 integrated system.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.(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: 6846896
• MDR Text Key: 85620561
• Report Number: 1319809-2017-00166
• 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: 09/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 1726926
• Device Lot Number: 1017-0245-0209
• Other Device ID Number: 10758750000012
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1