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

Catalog Number 8157596

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ and vitros na+ results were obtained from one level of vitros performance verifier control fluid on a vitros 350 chemistry system following calibration of new slide lots.A definitive assignable cause of higher than expected vitros na+ and vitros k+ quality control results could not be determined.Although a within run precision was not processed, the vtros 350 chemistry system is not a likely contributor to the event as the customer was able to obtain acceptable vitros k+ and acceptable vitros na+ results following recalibration with an alternate calibrator kit.Additionally, historical na+ and k+ quality control results were as expected, and the customers in use lots of vitros k+ and na+ continued to run as expected while troubleshooting the new reagent lots.The customer calibrated an alternate na+ slide lot with the alternate calibrator kit for investigation purposes and obtained acceptable results.The customer chose to move to that alternate na+ slide lot and therefore, it is unknown if vitros na+ lot 4231-1038-1417 would have performed acceptably using alternate calibrator kit.An unknown issue with vitros na+ lot 4231-1038-1417 cannot be ruled out.Continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1042-0596 and vitros na+ lot 4231-1038-1417.The customer did not provide their reconstitution protocol for calibrators or pv fluids.In addition, the customer obtained acceptable na+ and k+ results when calibrating with an alternate calibrator (kit 32) which is liquid ready to use.Therefore, a fluid handling issue when preparing calibrator or pv fluids cannot be ruled out as a potential cause of the event.Email address for contact office in field (b)(6).

Event Description

The investigation determined that higher than expected vitros potassium (k+) and vitros sodium (na+) results were obtained from one level of vitros performance verifier (pv) control fluid processed using a vitros 350 chemistry system.The vitros pv control was processed following a calibration event for new slide lots of vitros na+ and k+.Vitros pv lot r7909 vitros k+ result of 7.09 mmol/l versus expected result of 2.91 mmol/l vitros pv lot r7909 vitros na+ result of 180.0 mmol/l versus expected result of 117.1 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 higher than expected vitros k+ and vitros na+ results were obtained when testing quality control fluids.The customer made no allegation that patient sample results were affected.There was no allegation of patient harm.This report is number two 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.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ 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: joseph falvo ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11193047
• MDR Text Key: 241511195
• Report Number: 1319808-2021-00003
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1042-0596
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2020
• 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