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

Catalog Number 8157596

Device Problems High Test Results (2457); Low Test Results (2458)

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

Event Date 03/02/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher and lower than expected vitros na+ (sodium) and vitros k+ (potassium) results from non-vitros (randox) quality control fluids when tested two vitros 5600 integrated systems.The assignable cause of the higher and lower than expected results is unknown.However, since the quality control results shifted for vitros k+, vitros chloride (cl-), and two different lots of na+, using two different vitros 5600 systems, and shifted within calibration using the same reagent carts which produced acceptable results; the likely cause of the issue is fluid handling.The customer appears to be handling control fluids appropriately since the historical quality control results for vitros na+ and k+ are acceptable for both accuracy and within lab precision.If there was an issue with day to day quality control fluid handling, the within laboratory precision would not be acceptable.The likely cause of the shift in quality control is an issue with the electrolyte reference fluid (erf), either not warming fluid appropriately prior to loading, or an issue with the erf fluid.An analyzer or reagent issue are not likely contributors to the higher and lower than expected results.Although historical qc was not consistently acceptable, the customer was able to obtain acceptable results on the same lots of reagent that were in question once they began to run single lots of vitros na+ and k+ without processing multiple calibrations.Additionally, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros na+ lots 4226-1025-5201 and 4226-1024-5036, or for vitros k+ lot 4102-1027-4566.

Event Description

A customer obtained higher and lower than expected vitros na+ (sodium) and vitros k+ (potassium) results from non-vitros (randox) quality control fluids when tested two vitros 5600 integrated systems.Na+ lot 4226-1025-5201: j1 randox control l1 lot 138ul results 166.89, 168.51, 167.54 mmol/l vs expected result of 114.821 mmol/l.J1 randox control l3 lot 117ue results 123.25 mmol/l vs expected result of 159.341 mmol/l.J2 randox control l1 lot 138ul results 168.42, 167.45, 148.98 mmol/l vs expected result of 114.821 mmol/l.J2 randox control l3 lot 117ue results 122.15 mmol/l vs expected result of 159.341 mmol/l.Na+ lot 4226-1024-5036: j1 randox control l1 lot 138ul result 169.40 mmol/l vs expected result of 114.821 mmol/l.K+ lot 4102-1027-4566: j1 randox control l3 lot 117ue results 4.95 mmol/l vs expected result of 6.143 mmol/l.J2 randox control l3 lot 117ue results 4.83 mmol/l vs expected result of 6.145 mmol/l.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher and lower than expected vitros k+ and vitros na+ results were obtained when processing quality control fluids, and a patient sample processed for troubleshooting purposes.Ortho was not made aware of any allegation of patient harm.This report is number two of eleven mdr¿s for this event.Eleven 3500a forms are being submitted for this event as eleven devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4) and ivd (b)(4).

• Brand Name: VITROS CHEMISTY 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: 9903028
• MDR Text Key: 276228216
• Report Number: 1319809-2020-00042
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1027-4566
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2019
• 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