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

Catalog Number 8157596

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined the customer obtained higher than expected vitros na+ and vitros k+ results from a single patient sample processed using vitros chemistry products na+ slides lot 4211-0971-2325 and vitros chemistry k+ slides lot 4102-0978-3231 on a vitros 5,1 fs chemistry system (s/n (b)(4)).The assignable cause of the event could not be determined.Multiple products were affected and therefore a reagent performance issue is unlikely.As the issue started when the electrolyte reference fluid (erf) reservoir was changed, an unknown protocol issue with erf fluid handling that affected both the vitros na+ and k+ assays cannot be ruled out as contributing to the event.In addition, an instrument related issue cannot be ruled out as contributing to the event.Multiple service actions were performed to the vitros 5,1 erf module, including cleaning and replacing the erf tubing and tip carrier.Since the last service event, qc and performance verifier results have been acceptable, however, as pre-service within-run precision testing was not performed, it is unknown if the service actions alone resolved the issue.

Event Description

A customer observed higher than expected sodium (na+) and potassium (k+) results obtained from a single patient sample using vitros chemistry products na+ slides and vitros chemistry products k+ slides processed using a vitros 5,1 chemistry system.Vitros na+ results of 147.4 and 154.1 mmol/l vs.The expected result of 128.4 mmol/l.Vitros k+ result of 3.52 mmol/l vs.The expected result of 2.92 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected patient sample results were not reported outside the laboratory and there were no allegations of harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.(b)(4).This report is number three of three 3500a forms filed for this event, as three devices were involved.

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• 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; 513 technology blvd.; rochester NY 14652
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7395300
• MDR Text Key: 104820853
• Report Number: 1319809-2018-00063
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Medical Technologist
• Type of Report: Initial
• Report Date: 04/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2019
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0978-3231
• Other Device ID Number: 10758750010233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2017
• 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