MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS K+ SLIDES; IN-VITRO

Catalog Number 8157396

Device Problem Low Test Results (2458)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single patient sample using vitros k+ lot 4102-1063-0602 on a vitros xt 7600 chemistry system.The assignable cause of the unexpected results is unknown.The k+ results are discordant when comparing results obtained from a plain serum tube versus results from a sst.It is not anticipated that k+ results obtained from a plain serum tube and an sst would be different as they are both serum samples obtained during the same collection event.As the results are reproducible within each sample tube, pre-analytical sample mix-up could not be ruled out as a potential contributor.The customer was not following the collection device guidelines for sample preparation, therefore pre-analytical sample handling could not be ruled out as a contributor to the unexpected results.It was possible that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.The customer processed a vitros k+ precision which was within ortho acceptable guidelines, indicating that vitros k+ lot 4102-1063-0602 in combination with the vitros xt 7600 was operating as expected and not a likely contributor to the event.Historical quality control for vitros k+ lot 4102-1063-0602 was as expected, indicating that an issue with the reagent is not a likely contributor to the event.In addition, continual tracking and trending does not indicate a systemic issue with vitros k+ lot 4102-1063-0602.Email address for contact office above is (b)(6).

Event Description

The investigation determined that lower than expected vitros potassium (k+) results were obtained from a single patient sample using vitros k+ lot 4102-1063-0602 on a vitros xt 7600 chemistry system.Vitros k+ patient results of 4.8 and 4.8 mmol/l versus the expected result of 5.8 mmol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.No erroneous vitros 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 two of two mdr¿s for this event.Two 3500a forms are being submitted for this event as two devices were involved.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4) and (b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• Type of Device: IN-VITRO
• 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: laurie o'riordan ; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 13013915
• MDR Text Key: 288386041
• Report Number: 1319809-2021-00202
• Device Sequence Number: 1
• Product Code: CEM
• 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: 12/15/2021

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: 12/01/2022
• Device Catalogue Number: 8157396
• Device Lot Number: 4102-1063-0602
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/19/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1