MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1; IN VITRO DIAGNOSTICS

Catalog Number 1882208

Device Problem High Test Results (2457)

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

Event Date 10/27/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros glucose (glu) results were obtained from vitros performance verifiers (pv) processed using two different lots of vitros chemistry products glu slides on a vitros 5600 integrated system.The most likely cause of the higher than expected results is suboptimal calibrations likely caused by the customer not following ortho recommended protocol for preparation of the vitros calibrator kit 1 lot 0168.The customer likely used a calibrator that was past stability limits to calibrate the vitros glu reagent lots which led to the attainment of higher than expected quality control (qc) results.E-connectivity data also showed the customer was found to be calibrating too often even when qc was well within acceptable range based on historical quality control results, a vitros glu lot 0049-0967-1822 performance issue is not a likely contributor to the event as qc results showed the reagent to be accurate.The customer exhausted their inventory of vitros glu lot 0049-0967-1822 before a precision test could be run.There were no historical quality results for vitros glu lot 0049-0967-1888 because it was a new reagent lot and had only recently been calibrated and put into use.There is no evidence that the vitros 5600 integrated system malfunctioned.

Event Description

A customer reported higher than expected vitros glucose (glu) results obtained from vitros performance verifiers (pv) using vitros chemistry products glu slides on a vitros 5600 integrated system.Reagent lot 0049-0967-1888: vitros pvi h6976 result of 524.876 mg/dl vs the expected result of 78.9 mg/dl.Vitros pvii j6978 results of 530.363 and 520.71 mg/dl vs the expected result of 291.7 mg/dl.Reagent lot 0049-0967-1822: vitros pvii j6978 result of 530.026 mg/dl vs the expected result of 291.7 mg/dl.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected results were not reported from the laboratory.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint numbers (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
• 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: 9350919
• MDR Text Key: 220779058
• Report Number: 1319808-2019-00034
• Device Sequence Number: 1
• Product Code: JIX
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• 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: 1882208
• Device Lot Number: 0168
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 10/29/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2018
• 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