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

Catalog Number 6802584

Device Problem High Test Results (2457)

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

Event Date 07/26/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected creatinine (crea) results were obtained when a vitros performance verifier (pv) fluid was processed using vitros crea slide lot 1536-3509-6781 on a vitros 350 chemistry system.The assignable cause of the event was not determined.However, user error with incorrect calibration programming is a contributing factor to the event.The customer used calibrator fluid from kit lot 110 but the analyzer was programmed with calibrator kit lot 178.Therefore, the incorrect bottle values were used when generating the calibration data and caused the suboptimal calibration and unacceptable quality control (qc) results.A recalibration was performed using the appropriate calibrator kit lot number in the calibration program and the qc results post calibration were still higher than expected.The customer had no other inventory on site for continued investigation and is waiting for new product.The investigation is ongoing.A review of the performance of the vitros pv controls on the previous vitros crea slide lot indicated acceptable performance and it was concluded that the vitros pv fluid lots were not a likely contributor to the issue.An instrument issue could not be confirmed or ruled out as a potential contributing factor as no diagnostic precision testing was performed to assess the performance of the analyzer.A complaint review was performed on this slide lot and there was no indication of a quality issue with vitros crea slide lot 1536-3509-6781.In addition, continual tracking and trending of complaints has not identified any signals that would point to a systemic issue with vitros crea slide lot 1536-3509-6781.Email address for contact office above is (b)(6).

Event Description

A customer obtained higher than expected creatinine (crea) results when a vitros performance verifier (pv) fluid was processed using vitros crea slide lot 1536-3509-6781 on a vitros 350 chemistry system.Vitros pv1, lot u8105 results of 1.84, 2.0, 1.85, 1.87, 1.84 and 2.0 mg/dl versus the expected result (baseline mean) of 0.99 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The higher than expected vitros crea results were obtained when the customer was processing a non-patient fluid.However, the investigation cannot confirm that patient results would not be affected if the event were to recur undetected.There have been no allegations of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).This report is number one of six 3500a forms filed for this event, as six devices were affected.

• Brand Name: VITROS CHEMISTRY PRODUCTS CREA SLIDES
• Type of Device: IN-VITRO DIAGNOSTIC
• 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: 12360445
• MDR Text Key: 267953107
• Report Number: 1319809-2021-00126
• Device Sequence Number: 1
• Product Code: JFY
• 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: 08/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/02/2022
• Device Catalogue Number: 6802584
• Device Lot Number: 1536-3509-6781
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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