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

Catalog Number 1662659

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 09/08/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros na+ quality control results were obtained when processing non-vitros biorad lot 31830 controls and vitros performance verifier control lot l5005 on two vitros 5600 integrated systems.The investigation determined the assignable cause to be user error due to a combination of not calibrating na+ slides for an electrolyte reference fluid (erf) lot change and improper calibrator kit fluid preparation.The lower than expected biorad level 2 na+ result was obtained using a new vitros erf lot which was not the erf lot used during the initial na+ calibration event.In the ¿when to calibrate¿ section of the vitros na+ instructions for use (ifu) the customer is instructed to calibrate na+ whenever the vitros electrolyte reference fluid lot number changes.In response to the low biorad quality control results, the customer recalibrated vitros na+ multiple times using 2 different calibrator kit lots (lots 257 and 226) and obtained higher than expected quality control results on biorad and vitros performance verifier controls.It was concluded that the calibrator fluids were not prepared correctly which subsequently caused a suboptimal na+ calibration and the higher than expected biorad qc results.Acceptable vitros na+ quality control results were obtained after a recalibration event was performed using properly handled calibrator fluids and the new erf lot.The investigation found no indication the vitros 5600 chemistry system or vitros na+ slide lot contributed to the event.

Event Description

The investigation determined that higher and lower than expected vitros na+ quality control results were obtained when processing non-vitros biorad controls and vitros performance verifier controls on two vitros 5600 integrated systems.Vitros 5600 integrated system (s/n (b)(4)): (b)(6).Vitros 5600 integrated system (s/n (b)(4)): biorad lot 31831 level 1 = 139.34 and 141.66 mmol/l versus expected 124.3 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.It is unknown if patient results were reported during the time frame of the event.Ortho was not made aware of any misreported results and there was no allegation of patient harm as a result of this event.This report is number 1 of 3 mdr¿s for this event.Three (3) 3500a forms are being submitted for this event as 3 devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 6921622
• MDR Text Key: 90209789
• Report Number: 1319808-2017-00018
• Device Sequence Number: 1
• Product Code: JIX
• 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: 10/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2018
• Device Catalogue Number: 1662659
• Device Lot Number: 257
• Other Device ID Number: 10758750009503
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/08/2017
• Initial Date FDA Received: 10/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2016
• 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