MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS K+ SLIDES; IN VITRO DIAGNOSTICS

Catalog Number 8157596

Device Problem Low Test Results (2458)

Patient Problem Test Result (2695)

Event Date 10/09/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected potassium (k+) result was obtained from an american academy of family physicians (aafp) proficiency fluid sample processed using vitros chemistry products k+ slides lot 4102-1019-0649 in combination with a vitros 350 chemistry system.The assignable cause of this event was unable to be determined with the information provided.The quality control results provided by the customer show that the results were low outside of the assay sheet range of means for the month of october 2019, as well as on the day of the ch-11n fluid sample repeats in november 2019.Because the proficiency sample failure was isolated to vitros k+, possible causes of the event could be a suboptimal calibration, an issue isolated to the vitros k+ lot, cartridge handling or other unknown issue.Repeat testing of the proficiency fluids in november 2019 were within expectations, although it is unknown what the customer changed in order to achieve the acceptable results.Electrolyte reference fluid handling is not a likely cause, as the other two assays that use this fluid (vitros na+ and vitros cl-) passed the aafp proficiency testing.The customer did not process any within run precision testing, therefore, an issue with the vitros 350 chemistry system cannot be ruled out as a potential contributor to the event.

Event Description

A customer obtained a lower than expected potassium (k+) result obtained from an american academy of family physicians (aafp) proficiency fluid sample processed using vitros chemistry products k+ slides in combination with a vitros 350 chemistry system.Ch-11n vitros k+ result of 4.8 mmol/l versus an expected result of 5.8 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 lower than expected vitros k+ result was obtained when processing a proficiency fluid.No patient sample results have been questioned.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There were no allegations of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9461319
• MDR Text Key: 214627855
• Report Number: 1319809-2019-00120
• Device Sequence Number: 1
• Product Code: CEM
• 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: 12/12/2019

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: 12/01/2020
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1019-0649
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 12/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2019
• 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