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

Catalog Number 8433880

Device Problems High Test Results (2457); Low Test Results (2458); Calibration Problem (2890)

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

Event Date 10/25/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros lac quality control results were obtained from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.A definitive assignable cause could not be determined.There is no evidence that a vitros 350 system occurred.The unacceptable historical vitros lac quality control results obtained from the customer indicate that the vitros lac lot 3530-0092-3271 was not performing as intended.However, it is suspected that the customer is not following correct protocol when reconstituting the calibrator and control fluids but could not be confirmed.

Event Description

The customer observed higher and lower than expected vitros lac quality control results from vitros control fluids using two different lots of vitros lac slides on a vitros 350 chemistry system.Vitros lac lot 3530-0092-3271: pv2 lot k4852 vitros lac result 2.58*, 2.64*, 2.61*, 2.62*, 2.37*, 2.58*, 2.60*, 2.59*, 2.60*, 2.56*, 2.64*, 2.62*, 2.58*, 2.60*, and 2.61* mmol/l ,versus the expected vitros lac result 3.96 mmol/l; pv2 lot m5007 vitros lac results 5.09*, 2.54* and 5.19* mmol/l versus the expected vitros lac result 3.76 mmol/l.Vitros lac lot 3531-0093-5063: pv1 lot l5005 vitros lac result 2.13* mmol/l versus the expected vitros lac result 1.39 mmol/l; pv2 lot m5007 vitros lac result 5.67* mmol/l versus the expected vitros lac result 3.33 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action.Although there were no reports of affected patient sample results, it cannot be confirmed that patient sample results were not affected and would not be affected if the event were to recur undetected.There were no allegations of patient harm.This report is number four of twenty mdr's for this event.Twenty 3500a forms are being submitted for this event as twenty devices were involved.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS LAC 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: 6110944
• MDR Text Key: 60752581
• Report Number: 1319809-2016-00097
• 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: Medical Technologist
• Type of Report: Initial
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Technologist
• Device Expiration Date: 12/01/2017
• Device Catalogue Number: 8433880
• Device Lot Number: 3530-0092-3271
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2016
• 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