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

Catalog Number 8157596

Device Problem High Test Results (2457)

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

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ (potassium) and vitros na+ (sodium) results were obtained from a non-vitros (mas) quality control fluid when processed on two vitros 5600 integrated system (j1 and j2).The likely cause of the higher than expected vitros k+ and vitros na+ results is user error when preparing calibrator fluids.The customer used a 4ml pipette when preparing level 3 instead of a 3ml pipette.Incorrectly prepared calibrators would produce a suboptimal calibration affecting the accuracy obtained when testing quality controls.Review of calibration parameters confirmed a suboptimal calibration was the cause of the higher than expected results.Acceptable vitros k+ and vitros na+ quality control results were obtained after calibration with properly prepared calibrator fluids.Acceptable results were obtained from vitros k+ lot 4102-1013-8371 and vitros na+, lot 4225-1013-8887 when using correctly prepared calibrator fluids; therefore a reagent issue can be ruled out as the cause of the higher than expected results.

Event Description

A customer obtained higher than expected vitros k+ (potassium) and vitros na+ (sodium) results from a non-vitros (mas) quality control fluid when processed on two vitros 5600 integrated system (j1 and j2).Mas level 1, vitros na+ results: 159.6, 160.9 and 164.6 mmol/l on j1, and 154.0 mmol/l on j2 versus the expected result of 127.6 mmol/l.Mas level 1, vitros k+ result of 6.54 mmol/l on j1, and 6.53 and 6.57 and 6.53 mmol/l on j2 versus the expected result of 2.75 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros k+ and vitros na+ results were obtained when processing quality control fluids.However, the investigation cannot conclude that patient sample results were not or would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report is number one of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4) and ivd (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: 8727222
• MDR Text Key: 213706933
• Report Number: 1319809-2019-00044
• 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: 06/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2020
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1013-8371
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1