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 11/25/2020

Event Type  Injury  

Manufacturer Narrative

The investigation concludes that higher than expected vitros ca and crea results were obtained from multiple samples collected from the same patient tested on a vitros 4600 and 350 chemistry systems.The assignable cause for this event is most likely an unknown sample interferent isolated to samples collected from the affected patient.The affected patient was diagnosed with chronic lymphocytic leukemia.The customer stated there were no issues with vitros ca or crea quality control results during the timeframe of the event and indicated the issue was isolated to samples collected from the affected patient.In addition, the issue occurred over multiple slide lots for all the affected assays.Therefore, it is unlikely a vitros ca or crea reagent related performance issue did not likely contribute to the event.Continual tracking and trending of complaints has not identified any signals that would point to a potential systemic issue with vitros ca slides lots 0349-0606-3693 and 0302-0609-7760 or vitros crea slide lots 1536-3509-6040 and 1534-3504-8187.Since multiple assays and reagent slide lots are affected, and the issue is isolated to samples collected from this affected sample, and two different vitros systems were affected, an instrument related performance issue did not likely contribute to the event.However, since no diagnostic within-run precision testing was not performed on either vitros system an instrument related performance issue cannot be completely ruled out as contributing to the event.Email address for contact office is (b)(4).

Event Description

The customer reported higher than expected vitros calcium (ca) and creatinine (crea) results were obtained from multiple samples collected from a single patient using multiple slide lots of both assays processed on a vitros 4600 chemistry system and a 250 chemistry system.While the numeric ca results did not indicate an increased risk to patient safety, treatment was initiated based on the higher than expected vitros ca results reported outside of the laboratory.On (b)(6) 2020 sample vitros crea result of 183 umol/l vs.The non-vitros abbott result of 95 umol/l.On (b)(6) 2021 sample vitros crea result of 250 umol/l vs.The non-vitros roche result of 67 umol/l.On (b)(6) 2021 sample vitros crea result of 281 umol/l vs.The non-vitros roche result of 78 umol/l.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The vitros ca and crea patient results were reported outside of the laboratory and treatment was initiated based on the higher than expected vitros ca results.The patient was being followed by nephrologists for kidney failure, and was treated with i.V.Bisphosphonates for his apparent hypercalcemia starting in (b)(6) 2020.Treatment was discontinued in april 2021 after the nephrologist was concerned about the patient¿s decline in kidney function.Treatment with denosumab was started for one month, until it was determined the vitros ca results were positively biased.Per consultation with the ortho medical safety officer, there is no serious health impact expected from the changes in treatment due to the higher than expected ca results.However, unnecessary hospital visits during the covid-19 pandemic would also increase a chance for infection.Therefore, this event is classified as a potential serious injury.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).This report is number four of four 3500a forms filed for this event, as four 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: 12180295
• MDR Text Key: 261916483
• Report Number: 1319809-2021-00120
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2022
• Device Catalogue Number: 6802584
• Device Lot Number: 1534-3504-8187
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2021
• 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