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

Catalog Number 1662659

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros k+ result was obtained on a vitros 5600 integrated system.The event was isolated to the calibration event performed on (b)(6) 2017.The calibration was suboptimal as shown by the high recovery of the post calibration quality control results.The most likely cause of the suboptimal (b)(6) calibration was user error, where the calibrator lyophilate was reconstituted with an incorrect volume of diluent, however, this could not be confirmed.There was no evidence that the vitros 5600 integrated system or vitros k+ malfunctioned.

Event Description

A customer obtained a higher than expected vitros k+ result when testing a quality control fluid on a vitros 5600 integrated system.Vitros k+ result 7.24 mmol/l vs.Expected vitros k+ result 2.89 mmol/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 higher than expected vitros k+ result was generated from testing a quality control fluid.Patient results were also affected, however the magnitude of the bias did not constitute a potential health and safety event, and no action was taken by the physician due to the reported results.There were no allegation of patient harm as a result of this event.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATORY 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: 6362696
• MDR Text Key: 68972186
• Report Number: 1319808-2017-00005
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 02/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2018
• Device Catalogue Number: 1662659
• Device Lot Number: 0226
• Other Device ID Number: 10758750009503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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