MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS, INC. VITROS CHEMISTRY PRODUCTS CREA SLIDES; IN VITRO DIAGNOSTCS

Catalog Number 6802584

Device Problem High Test Results (2457)

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

Event Date 12/28/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that higher than expected vitros crea results were obtained when processing a patient sample on a vitros 350 chemistry system when compared with the repeat result issued in the corrected report.The assignable cause of the event was not determined.Historical quality control results do not indicate an accuracy issue with vitros crea slide lot 1545- 3542-5777 as a cause of the event.Acceptable diagnostic within run precision test results do not indicate an issue with the performance of vitros 350 chemistry system in combination with vitros crea slide lot 1545-3542-5777 as a cause of the event.In addition, continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros crea slide lot 1545-3542-5777.It is unknown if the customer is following the collection device manufacturer¿s centrifugation recommendations when processing the patient sample.Therefore, a sample related issue may have contributed to the event.A patient scheduled for hemorrhoidectomy had their surgery canceled due to a higher-than-expected vitros creatinine result.As per medical consultation with an ortho medical safety officer: an elective hemorrhoidectomy surgery may be postponed without patient consequences since the patients are often stable and are not at risk of immediate deterioration in health.Likewise, an emergency hemorrhoidectomy may be delayed for a short period while the patient is managed with non-surgical treatment pending a definitive surgical intervention efficiently when the risk of surgery outweighs the benefit.However, in a severe strangulated hemorrhoid, a delay may result in a serious patient outcome, e.G., intestinal gangrene.A patient with evidence of renal failure (high creatinine) may be at increased risk of serious injury during or post-surgery.In this case, the patient was managed successfully despite the one-day delay.Thus, the risk of serious short or long-term patient harm due to this failure mode is remote.

Event Description

The customer reported they obtained higher than expected vitros creatinine (crea) results when processing a patient sample on a vitros 350 chemistry system when compared with the crea result obtained upon repeat testing using the same patient sample.Vitros crea results 349, 357 umol/l versus the repeat vitros crea result of 50 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if the results were to recur undetected.The higher than expected vitros crea result was reported from the laboratory and a hemorrhoidectomy surgery was cancelled as the laboratory investigated the patients crea results.The surgery was completed the next day after a corrected report was issued.There was no allegation of patient harm due to the delay of the scheduled surgery.This report is number one 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.Complaint numbers (b)(4) and reportability assessment ra604720.

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN VITRO DIAGNOSTCS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer (Section G): ORTHO-CLINICAL DIAGNOSTICS, INC.; 513 technology boulevard; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; microtyping systems; 1295 southwest 29th avenue; pompano beach, FL 33069 ; 9549709500
• MDR Report Key: 18563703
• MDR Text Key: 333510694
• Report Number: 0001319809-2024-00004
• Device Sequence Number: 1
• Product Code: JFY
• UDI-Device Identifier: 10758750002849
• UDI-Public: 10758750002849
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/22/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6802584
• Device Lot Number: 1545-3542-5777
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2023
• Initial Date FDA Received: 01/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1