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 Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected lactate (lac) results were obtained from non-vitros thermofisher mas quality control (qc) fluids using vitros chemistry products lac slides lot 3530-0112-4269, and higher than expected glucose (glu) results were obtained from a single patient sample, two different api proficiency fluids, a non-vitros thermofisher mas qc fluid and a vitros performance verifier (pv) using vitros chemistry products glu slides lot 0008-3214-3872.The results were all obtained on a vitros 4600 chemistry system.The most likely cause of the higher than expected vitros lac and vitros glu results is a suboptimal calibration due to improper protocol.The customer indicated that when they reconstituted the calibrator fluids that were used for the initial vitros lac and vitros glu calibrations that they used all 5ml of diluent rather than 3ml of diluent as specified in the vitros cal kit 1 instructions for use (ifu).Additionally, the customer thawed the vitros calibrator kit overnight in the refrigerator.Once the customer performed an alternate calibration using correct fluid handling protocol, the customer obtained expected results for vitros lac and vitros glu.Although there were no historical quality control results available for review as the vitros lac and glu slides lots were new lots for the customer, an issue with the vitros lac lot 3530-0112-4269 or vitros glu lot 0008-3214-3872 is not a likely contributing factor to the event.Furthermore, continual tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros lac lot 3530-0112-4269 or vitros glu lot 0008-3214-3872.A diagnostic precision test was not processed, however, an analyzer issue is not a likely contributor to the event as the customer reported no issues with their prior lots of vitros glu and vitros lac, and the issue with the new lots was resolved with a new calibration.(b)(4).

Event Description

A customer reported higher than expected lactate (lac) results obtained from non-vitros thermofisher mas quality control (qc) fluids using vitros chemistry products lac slides, and higher than expected glucose (glu) results obtained from a single patient sample, two different api proficiency fluids, a non-vitros thermofisher mas qc fluid and a vitros performance verifier (pv) using vitros chemistry products glu slides.The results were all obtained on a vitros 4600 chemistry system.Vitros lac mas chemtrak-h l1 results of 2.10 and 2.02 mmol/l versus the expected result of 1.26 mmol/l.Vitros lac mas chemtrak-h l3 results of 10.11 and 9.98 mmol/l versus the expected result of 5.78 mmol/l.Vitros glu mas chemtrak-h l3 results of 527.9, 521.0, 532.2, 532.3 and 537.9 mg/dl versus the expected result of 313 mg/dl.Vitros glu pvii lot q7692 results of 511.9 and 512.2 mg/dl versus the expected result of 299.3 mg/dl.Vitros glu patient sample results of 463 and 461 mg/dl vs the expected result of 279 mg/dl.Vitros glu api sample ch-11 result of 330 mg/dl vs the expected result of 195 mg/dl.Vitros glu api sample ch-13 result of 343 mg/dl vs the expected result of 205.5 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 vitros lac and vitros glu results obtained from the quality control and proficiency fluids were not reported from the laboratory.Additionally, the higher than expected patient results were obtained during troubleshooting and were not reported from the laboratory.However, it could not be concluded that patient samples 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 number (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: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11378080
• MDR Text Key: 265181504
• Report Number: 1319808-2021-00006
• 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: 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2022
• Device Catalogue Number: 1882208
• Device Lot Number: 0190
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/31/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/10/2020
• 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