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

Catalog Number 8157596

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected potassium (k+) result was obtained from a vitros performance verifier (lot k4852) quality control fluid processed using vitros k+ microslides on a vitros 250 chemistry system.The assignable cause was determined to be user error.The customer failed to calibrate vitros k+ microslides with a reference fluid lot change.The vitros k+ instructions for use instructs the customer to calibrate when the vitros reference fluid lot number changes.Acceptable quality control results were obtained after k+ calibration with the new reference fluid lot.There is no indication of a vitros k+ reagent issue or a vitros 250 system issue.

Event Description

The investigation determined that a lower than expected potassium (k+) result was obtained from a vitros performance verifier (lot k4852) quality control fluid processed using vitros k+ microslides on a vitros 250 chemistry system.Vitros performance verifier fluid (k4852) k+ result of 4.7 mmol/l versus an expected result of 5.6 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 unexpected vitros k+ result was generated from a non-patient fluid, however the investigation cannot conclude that patient sample results were not affected and would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• Type of Device: IN VITRO DIAGNOTICS
• 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: 6824780
• MDR Text Key: 84002225
• Report Number: 1319809-2017-00161
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2017

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: 05/01/2018
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-0963-7090
• Other Device ID Number: 10758750010233
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2017
• Initial Date FDA Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2016
• 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