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 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ (potassium) results were obtained from a vitros performance verifier fluid when processed on a vitros 5600 integrated system.The likely cause of the higher than expected k+ results is a suboptimal calibration due to protocol issues when preparing calibrator kit 2.An acceptable within run na and k+ precision tests were processed indicating an instrument issue was not a contributing factor.Acceptable k+ quality control results were obtained after restoring the calibration curve generated prior to the calibration event on (b)(6) 2020 indicating the higher than expected k+ results was due to a suboptimal calibration.The customer is a new vitros user and agrees the likely cause of the higher than expected k+ results was an issue when preparing calibrator kit 2 fluids.The vitros 5600 integrated system or vitros k+ slides lot 4102-1028-5193 did not malfunction.

Event Description

A customer obtained higher than expected vitros k+ (potassium) results from a vitros performance verifier fluid when processed on a vitros 5600 integrated system.Vitros performance verifier i fluid (lot h6976), vitros k+ results of 3.9 and 4.0 mmol/l versus the midpoint of the rom (range of mean) of 2.86 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The customer did not process patient samples after obtaining unacceptable vitros k+ quality control results.Ortho has not been made aware of any allegation of 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: 9749611
• MDR Text Key: 223667399
• Report Number: 1319808-2020-00014
• 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: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Catalogue Number: 1662659
• Device Lot Number: 0298
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2019
• 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