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 Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros k+ and na+ results were obtained from a non-vitros biorad level 1 quality control fluid processed using vitros k+ and na+ slides in combination with a vitros 5600 integrated system and a vitros 4600 chemistry system.The assignable cause was most likely atypical calibrations.The calibrations were suboptimal when compared to typical calibration responses and parameters with responses from level 3 of the calibrator for both instruments being higher than the database.The issue was resolved by recalibrating with freshly reconstituted calibrator vials and using the same vitros na+ and vitros k+ reagent lots.The historical quality control results indicate both the vitros na+ lot and vitros k+ lot in combination with both the vitros 5600 and vitros 4600 systems were performing as expected.There is no indication of a reagent issue or an instrument issue.

Event Description

A customer reported higher than expected qc results obtained using vitros potassium (k+) slides and vitros sodium (na+) slides on a vitros 5600 integrated system and a vitros 4600 chemistry system.Non-vitros biorad quality control fluid level 1 (lot 45771): vitros k+ result on vitros 5600 3.59 mmol/l versus expected vitros k+ result 2.72 mmol/l; vitros k+ result on vitros 4600 3.60 mmol/l versus expected vitros k+ result 2.72 mmol/l; vitros na+ result on vitros 5600 149.8 mmol/l versus expected vitros na+ result 118.1 mmol/l; vitros na+ result on vitros 4600 147.7 mmol/l versus expected vitros na+ result 118.1 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 unexpected vitros na+ and k+ results were generated from non-patient fluids and there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (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: 7994158
• MDR Text Key: 126236711
• Report Number: 1319808-2018-00041
• 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: 10/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Catalogue Number: 1662659
• Device Lot Number: 0277
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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