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

Catalog Number 8157596

Device Problem Low Test Results (2458)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected k+ result was obtained from a non vitros quality control fluid processed using vitros chemistry products k+ slides, lot 4102-0974-1384 on vitros 5600 integrated system (b)(4).The most likely assignable cause is user error.The customer failed to calibrate vitros k+ when the lot of electrolyte reference fluid was changed.The vitros k+ slides instructions for use (ifu) instructs the user to calibrate the k+ slides when the vitros reference fluid lot number changes.After calibrating vitros k+ lot 4102-0974-1384 using the new erf lot, acceptable vitros k+ quality control performance was observed.There was no indication that the vitros 5600 integrated system, or the vitros slide lot in use malfunctioned.

Event Description

A customer observed a lower than expected potassium (k+) result obtained from a non-vitros quality control (qc) fluid, using vitros chemistry products k+ slides processed using a vitros 5600 integrated chemistry system.Level 2 bio rad control lot 26412 vitros k+ result 4.90 mmol/l versus expected k+ result 6.0 mmol/l biased results of the direction and magnitude observed may lead to inappropriate physician action if patient samples were affected.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.(b)(4).

• 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: 6790985
• MDR Text Key: 83839566
• Report Number: 1319809-2017-00147
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 08/14/2017

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: 11/01/2018
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0974-1384
• Other Device ID Number: 10758750010233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1