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

Catalog Number 1662659

Device Problem High Test Results (2457)

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

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros na+ (sodium) and k+ (potassium) results were obtained when testing a non-vitros (biorad) quality control fluid when tested on two different vitros 5600 integrated systems (b)(4).The investigation determined the most likely assignable cause of the higher than expected na+ and k+ results on both vitros 5600 systems is a suboptimal calibration caused by user error.The cause of the suboptimal calibration is due to the improper preparation of calibrator kit 2.A subsequent calibration with correctly prepared fluids produced acceptable results.Historical vitros na+ and k+ quality control results indicate acceptable performance prior to the calibration event on (b)(6) 2019.In addition, the quality control results were acceptable after the customer performed a new calibration on both systems with properly prepared fluids.There was no evidence to suggest a malfunction of either vitros 5600 system, vitros na+ lot 4223-1009-7288 or vitros k+ lot 4102-1012-7985 contributed to the event.

Event Description

A customer obtained higher than expected vitros na+ (sodium) and k+ (potassium) results when testing a non-vitros (biorad) quality control fluid when tested on two different vitros 5600 integrated systems (b)(4).Vitros na+ result 160.4 mmol/l versus expected na+ l1 baseline mean of 117.0 mmol/l vitros k+ results 3.80, 3.79, 3.85, 3.83 mmol/l versus the expected k+ l1 baseline mean of 2.70 mmol/l.(b)(4).Vitros na+ result 158.9, 159.3, 159.8, 160.2 and 160.5 mmol/l versus expected na+ l1 baseline mean 117.0 mmol/l.Vitros k+ results 3.73, 3.77, 3.81, 3.82, and 3.85 mmol/l versus the expected k+ l1 baseline mean 2.70 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros na+ and k+ results were obtained when the customer was processing a non-patient fluid, and no patient results were reported during the timeframe of the event.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (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: 8825751
• MDR Text Key: 217162585
• Report Number: 1319808-2019-00020
• 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: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1662659
• Device Lot Number: 288
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2018
• 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