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 Known Impact Or Consequence To Patient (2692)

Event Date 07/03/2020

Event Type  malfunction  

Manufacturer Narrative

The customer contacted the tsc to report higher than expected vitros sodium (na+) and vitros potassium (k+) results obtained on a vitros performance verifier quality control fluid processed using a vitros 5,1 fs system.The assignable cause of the higher than expected results obtained for the two na samples (lot 4227-1027-6241 ) and the two k+ samples (lot 4102-1021-1532 ) is likely related to improper fluid handling.The customer was not warming or mixing the erf per the ifu instructions prior to loading on analyzer.The assignable cause of the higher than expected results on one na+ sample (lot 4227-1027-6241 ) and one k+ sample (lot 4102-1024-3511 ) is unknown.The customer indicated that they were following proper warming procedures, however upon loading fresh erf at a later date without tsc guidance, results were out of range again.An issue with erf lot p7726 is not likely, as the customer was able to get acceptable results while running this lot of erf.Additionally, the customer is not using a correct fixed volume pipette for reconstitution of calibrators and qc fluid- the customer indicated that they reconstituted using a mouth pipette, which is unacceptable per the ifu¿s for all vitros calibrators and control fluids.A vitros precision test was not run, however an instrument issue is unlikely to be the cause of the higher than expected results as acceptable results were obtained using multiple reagents lots and erf lots with no corrective action made to the analyzer.Based on the limited historical qc, an issue with vitros na+ lot 4227-1027-6241, and vitros k+ lots 4102-1021-1532 and 4102-1024-3511 is not a likely contributor to the higher than expected results.The customer was able to obtain acceptable results on all of these lots when correct fluid handling protocol was followed.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros na+ lot 4227-1027-6241 and vitros k+ lots 4102-1021-1532 and 4102-1024-3511.

Event Description

The customer contacted the tsc to report higher than expected vitros sodium (na+) and vitros potassium (k+) results obtained on a vitros performance verifier quality control fluid processed using a vitros 5,1 fs system.Na+ lot 4227-1027-6241: vitros na+ pvi lot j6662 results of 155.98 and 156.96 mmol/l versus the biorad baseline mean of 118.10 mmol/l.K+ lot 4102-1021-1532: vitros k+ pvi lot f6662 results of 3.72, 3.71 mmol/l versus the pvi baseline mean of 2.923 mmol/l.The assignable cause of the higher than expected results obtained is likely related to improper fluid handling.The customer was not warming or mixing the erf per the ifu instructions prior to loading on analyzer.Na+ lot 4227-1027-6241: vitros na+ pvi lot j6662 results of 149.63 mmol/l versus the biorad baseline mean of 118.10 mmol/l.K+ lot 4102-1024-3511: vitros k+ pvi lot f6662 results of 3.73 mmol/l versus the pvi baseline mean of 2.923 mmol/l.The assignable cause of the higher than expected results is unknown.The customer indicated that they were following proper warming procedures, however upon loading fresh erf at a later date without tsc guidance, results were out of range again.An issue with erf lot p7726 is not likely, as the customer was able to get acceptable results while running this lot of erf.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected on patient samples.No erroneous vitros na+ or k+ patient results were reported from the laboratory.There was no allegation of patient harm as a result of this event.This report is number 4 of 6 mdr¿s for this event.Six (6) 3500a forms are being submitted for this event as six 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 10361636
• MDR Text Key: 245928056
• Report Number: 1319809-2020-00081
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 08/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2021
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1021-1532
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/07/2020
• Initial Date FDA Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2019
• 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