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 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitros k+ result was obtained from vitros quality control fluid on vitros chemistry products k+ slides and vitros performance verifier ii fluid on a vitros 250 chemistry system.The root cause of this event is unknown.Qc was as expected following the service actions of the ortho fe, which included replacing the erf metering pump, adjusting and tightening screws to the electrometer, cleaning the microslide incubator, and replacing the evaporation caps.All marker precision tests passed within expectation, indicating that the instrument is operating as expected following service actions.However, the instrument cannot be confirmed or ruled out as the potential cause of the events, as the marker precision tests were not run prior to the service actions.Fluid and reagent handling protocols were not confirmed with the customer, and therefore cannot be ruled out as a potential cause of the events.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ lot 4102-1013-8191.

Event Description

An ortho clinical diagnostic (ortho) laboratory specialist (ls) contacted the technical solution center (tsc) on behalf of a customer that had observed a lower than expected vitros chemistry products k+ slides result when testing vitros quality control (qc) fluid on a vitros 250 chemistry system.Vitros pvii lot c6274 vitros k+ result 4.97 versus the vitros k+ baseline mean of 5.51 mmol/l.The lower than expected vitros k+ results were obtained on vitros qc fluid.There was no report of affected patient samples, however; the investigation cannot conclude that patient sample results had not been affected or would not be affected if the event were to recur undetected.There was no allegation 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: 9466954
• MDR Text Key: 214628544
• Report Number: 1319809-2019-00121
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1013-8191
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1