MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN-VITRO DIAGNOSTIC

Catalog Number 1662659

Device Problem Low Test Results (2458)

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

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros na+ result was obtained when performing a patient sample correlation on a vitros 4600 chemistry system.The likely cause of lower than expected vitros na+ result is a suboptimal calibration.However, the cause of the suboptimal calibration could not be definitively determined.A diagnostic within run vitros na+ precision test was not performed to evaluate the performance of the vitros 4600 system, therefore, the vitros 4600 system could not be entirely ruled out as a contributor of the event.As vitros na+ lot 4219-0991-0597 had not been put into use, historical vitros na+ quality control results were not available to evaluate the performance of vitros na+ lot 4219-0991-0597.Therefore an issue with the reagent could not be entirely ruled out as a contributor of the event.The lower than expected vitros na+ result was likely caused by a suboptimal calibration event on (b)(6) 2018 likely due to a calibrator handling issue.Acceptable performance was observed using freshly prepared calibrators without altering the condition of the vitros 4600 system.This would indicate that both vitros na+ lot 4219-0991-0597 and the vitros 4600 system did not contribute to the suboptimal calibration.

Event Description

A customer obtained a lower than expected vitros sodium (na+) result when performing a patient sample correlation on a vitros 4600 chemistry system.Patient sample 20 vitros na+ result 144 mmol/l versus the expected vitros na+ result 151 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the event were to occur undetected.The lower than expected na+ result was obtained while performing a patient sample correlation and was not reported outside of the laboratory.However the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7764842
• MDR Text Key: 117014293
• Report Number: 1319808-2018-00022
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/22/2019
• Device Catalogue Number: 1662659
• Device Lot Number: 0267
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2017
• 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