MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2; IN VITRO DIAGNOSTICS

Catalog Number 1662659

Device Problem High Test Results (2457)

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

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ and vitros na+ results were obtained when testing one level of non-vitros biorad control fluid on a vitros 5600 integrated system.A definitive assignable cause of higher than expected vitros na+ and vitros k+ quality control results is user error.The customer is not following proper calibrator fluid handling, which led to suboptimal calibrations.The customer indicated that they freeze calibrators for later use and stated that the calibrators in use for the initial two calibrations were not prepared fresh.Per the vitros calibrator kit 2 instructions for use it is stated that calibrators must be used within 24 hours of reconstitution and then discarded.The customer also indicated that they used a 1ml pipette to reconstitute a set of calibrators which is not recommended per the instructions for use.Once the customer prepared fresh calibrators using 3ml glass volumetric pipettes the calibration was as expected and qc results were within the customers acceptable range.The quality control results obtained after the most recent calibration event indicate vitros k+ lot 4102-1031-6623 and vitros na+ lot 4227-1027-6000 in combination with the vitros 5600 integrated system are performing as expected when compared to the customers baseline data.In addition, continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1031-6623 and vitros na+ lot 4227-1027-6000.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) after observing higher than expected vitros potassium (k+) and vitros sodium (na+) results when testing non-vitros biorad quality control (qc) fluid on a vitros 5600 integrated system.Biorad l1 lot 45861 vitros k+ results of 3.56, 3.68, 3.55 mmol/l versus expected vitros k+ result 2.60 mmol/l.Biorad l1 lot 45861 vitros na+ results of 136.4, 144.0, 150.1, 139.0, 147.8, 137.6 mmol/l versus expected vitros na+ result 116.0 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 4 of 4 mdr¿s for this event.Four (4) 3500a forms are being submitted for this event as 4 devices were involved.This report corresponds to ortho clinical diagnostics inc.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 2
• 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; 1000 lee road; rochester NY 14606
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10501946
• MDR Text Key: 233927446
• Report Number: 1319808-2020-00037
• Device Sequence Number: 1
• Product Code: JIX
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2021
• Device Catalogue Number: 1662659
• Device Lot Number: 0229
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/10/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1