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 Known Impact Or Consequence To Patient (2692)

Event Date 12/28/2015

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, higher than expected vitros k+ result was obtained from a single patient sample using vitros k+ reagent processed on a vitros 5600 integrated system.The assignable cause of the event is unknown; however, a pre-analytical sample processing or a sample quality issue cannot be ruled as a contributing factor.The investigation was able to rule out a vitros k+ reagent issue or vitros instrument issue as possible contributing factors.The lower than expected vitros k result was reported outside of the laboratory, however, there was no allegation of patient harm as a result of this event.

Event Description

A customer complained of a non-reproducible, lower than expected vitros k+ result obtained from a single patient sample using vitros k+ reagent processed on a vitros 5600 integrated system.Patient result of 4.9 mmol/l vs.Expected 6.7 mmol/l the lower than expected result was reported outside of the laboratory and the result was questioned by a physician before any actions were taken.There was no allegation of patient harm.This report corresponds to ortho clinical diagnostics inc.Complaint number (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: 5386596
• MDR Text Key: 36772542
• Report Number: 1319809-2016-00003
• 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: 01/22/2016

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: 04/01/2017
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0942-7493
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/28/2015
• Initial Date FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2015
• 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