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

Catalog Number 8433880

Device Problems High Readings (2459); Low Readings (2460)

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

Event Date 10/08/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that the customer obtained higher and lower than expected vitros lactate quality control (qc) results using the vitros 5600 integrated system.The assignable cause of the event is most likely the use of sub-optimal calibrations that subsequently caused the higher and lower than expected lactate quality control results.The customer obtained multiple sub-optimal calibration parameters when compared to expected parameters using the same vitros lactate lot with three different calibrator kit lots and therefore, it is not likely that the issue was related to the calibrator kit lots themselves.Improper pre-analytical calibrator fluid handling is a likely contributing factor, but this could not be definitively confirmed.A successful recalibration using the same lactate lot was obtained with no changes to the instrument or the lactate reagent.A malfunction of the vitros 5600 integrated systems or a vitros lac reagent lot issue are not likely contributors to this event.

Event Description

A customer obtained higher and lower than expected vitros lactate quality control results while using the vitros 5600 integrated system.Vitros l1= 2.57, 2.58 vs.Expected 1.34 mmol/l; vitros l2= 7.11, 7.11, 7.11, 7.18 vs.Expected 3.84 mmol/l; biorad l1= 4.84 vs.Expected 5.86 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 lactate results were generated from non-patient fluids, 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 is number five of seven mdr¿s for this event.Seven 3500a forms are being submitted for this event as seven devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LAC 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: 6077396
• MDR Text Key: 59556965
• Report Number: 1319809-2016-00091
• Device Sequence Number: 1
• Product Code: KHP
• 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: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2017
• Device Catalogue Number: 8433880
• Device Lot Number: 3531-0091-1618
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1