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

Catalog Number 8157596

Device Problem Low Test Results (2458)

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

Event Date 08/21/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros k+ result was obtained from a single patient sample tested on a vitros 5600 integrated system.The initial result was lower than expected compared to the repeat vitros k+ result obtained from the same sample.A definitive assignable cause for the event could not be determined with the information provided.Pre-analytical sample processing could not be ruled out as a contributing factor.It was not possible to establish if the customer was following the sample collection device manufacturer¿s recommendation for sample centrifugation.Cellular debris due to poor sample preparation was likely present in the affected sample, although this could not be confirmed.An instrument malfunction and unexpected instrument performance cannot be ruled out as a likely contributor to the event.Diagnostic precision testing to assess instrument performance was not performed by the customer when requested.Based on historical quality control results a vitros k+ slide lot 4102-1034-8350 reagent performance issue is not a likely contributor to the event as all quality control results were within established ranges.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros k+ slide lot 4102-1034-8350.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report a lower than expected potassium result that was obtained from a patient sample tested using the in-use lot of vitros potassium (k+) slides on a vitros 5600 integrated system.Patient sample 2 vitros k+ result of 3.0 mmol/l vs.The expected result of 5.6 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 customer could not confirm if the lower than expected k+ result was reported outside of the laboratory.There was no reported 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 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: 10613570
• MDR Text Key: 244157034
• Report Number: 1319809-2020-00114
• Device Sequence Number: 1
• Product Code: CEM
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 10/01/2020

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: 09/21/2021
• Device Catalogue Number: 8157596
• Device Lot Number: 4102-1034-8350
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/03/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2020
• 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