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

Catalog Number 8157596

Device Problem Low Test Results (2458)

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

Event Date 06/01/2021

Event Type  malfunction  

Event Description

The investigation determined that a lower than expected potassium (k+) result was obtained from a patient sample using vitros chemistry products k+ slides lot 4102-1053-7059 on a vitros 5600 integrated system.Vitros k+ patient result of 4.16 mmol/l vs an expected result of 5.54 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 lower than expected vitros k+ patient sample result was reported from the laboratory.However, no treatment was initiated, altered or stopped based on the reported result.The sample was later re-processed and a corrected report was issued.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho) complaint number (b)(4).

Manufacturer Narrative

The investigation determined that a lower than expected potassium result was obtained from a patient sample using vitros chemistry products k+ slides lot 4102-1053-7059 on a vitros 5600 integrated system.The assignable cause of the event is likely related to pre-analytical sample handling.The customer is not adhering to the sample collection device manufacturer¿s recommendations for sample centrifugation.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.The patient sample initially produced lower than expected results.When the same sample was repeated on the same and a different analyzer, results were as expected with no other actions to the analyzer or to the sample.Historical vitros k+ lot 4102-1053-7059 was within expectation, indicating acceptable vitros k+ slide performance.Additionally, vitros na+, k+, and alkp precision tests were all within ortho acceptable guidelines, indicating that the vitros 5600 integrated system was operating as expected.(b)(4).

• Brand Name: VITROS CHEMISTRY PRODUCTS K+ SLIDES
• Type of Device: IN-VITROS DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• MDR Report Key: 12078865
• MDR Text Key: 281530714
• Report Number: 1319809-2021-00110
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial
• Report Date: 06/28/2021

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: 09/01/2022
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1053-7059
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 06/02/2021
• Initial Date FDA Received: 06/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1