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 Insufficient Information (4580)

Event Date 01/14/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros crea results were obtained for multiple patient samples using a single cartridge of vitros crea when tested on a vitros 350 chemistry system.The higher than expected vitros crea results were reported outside of the laboratory, and treatment was initiated based on the reported vitros results.The assignable cause of the event was related to the vitros crea cartridge in use when the event occurred.The affected patient results were all processed on the same vitros crea reagent cartridge.Acceptable vitros crea performance was obtained when the customer put a new vitros crea cartridge into use.The vitros crea slide cartridge which produced the higher than expected results is no longer available for further and the issue with the cartridge that caused the higher than expected results is unknown.Historical quality control results were acceptable, indicating that vitros crea slide lot 1531-3499-6502 did not likely contribute to the event.Continual tracking and trending does not indicate a systemic quality issue with vitros crea lot 1531-3499-6502.Although the customers sample handling protocol was not provided and a within run precision was not performed to confirm analyzer performance, these are not likely contributors to the higher than expected results as the customer was able to get acceptable results with an alternate vitrso crea cartridge with no other actions.

Event Description

The investigation determined that higher than expected vitros crea results were obtained for multiple patient samples using a single cartridge of vitros crea when tested on a vitros 350 chemistry system.Patient sample 2 vitros crea result of 6.04 mg/dl vs.The expected result of 0.66 mg/dl.Patient sample 3 vitros crea result of 2.21 mg/dl vs.The expected result of 0.86 mg/dl.Patient sample 4 vitros crea result of 2.69 mg/dl vs.The expected result of 0.72 mg/dl.Patient sample 5 vitros crea result of 5.58 mg/dl vs.The expected result of 0.93 mg/dl.Patient sample 7 vitros crea result of 1.91 mg/dl vs.The expected result of 0.99 mg/dl.Patient sample 8 vitros crea result of 2.79 mg/dl vs.The expected result of 0.82 mg/dl.Patient sample 11 vitros crea result of 1.80 mg/dl vs.The expected result of 0.79 mg/dl.Patient sample 12 vitros crea result of 2.78 mg/dl vs.The expected result of 0.93 mg/dl biased results of the magnitude and direction observed may lead to inappropriate physician action if patient samples were affected.The higher than expected vitros crea results were reported outside of the laboratory.One patient was sent to the emergency room for an ultrasound and additional bloodwork.A consultation with an ortho medical safety officer indicated that although these tests were probably unnecessary, serious patient risk is not expected.Corrected reports were issued for all patients and there was no allegation of patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc.(b)(4).This report is number two of eight 3500a forms filed for this event, as eight 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; 100 indigo creek drive; rochester NY 14626
• Manufacturer Contact: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11313141
• MDR Text Key: 259577310
• Report Number: 1319681-2021-00014
• Device Sequence Number: 1
• Product Code: JFY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2021

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: 07/01/2021
• Device Catalogue Number: 6802584
• Device Lot Number: 1531-3499-6502
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2021
• 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