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

Catalog Number 6802584

Device Problem Low Test Results (2458)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/22/2018

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a non-reproducible, lower than expected vitros crea result was obtained from a single patient sample using vitros crea slide lot 1515-377-8249 on a vitros 5600 integrated system.The most likely assignable cause of the event is a sample related issue.A visual examination of the affected sample determined that a large fibrin clot was floating in the sample.It is likely that this cellular debris, due to poor sample preparation, contributed to the event, although this could not be confirmed.Precision performance testing used to assess the performance of the vitros 5600 system was within acceptable guidelines, indicating that the vitros 5600 analyzer was performing as intended at the time of the event.Historical vitros crea quality control results were acceptable, indicating that vitros crea slide lot 1515-3477-8249 was performing as intended.There is no indication that the vitros 5600 system or affected vitros crea slide malfunctioned.

Event Description

A customer observed a non-reproducible, lower than expected vitros crea result from a single patient sample when using vitros creatinine (crea) slides on a vitros 5600 integrated system.Patient sample crea result of 0.69 mg/dl versus the expected result of 4.91 mg/dl.Biased results of the direction and magnitude observed may lead to inappropriate physical action if the event were to occur undetected.The lower than expected crea result was reported outside of the laboratory, however, the result was questioned by a physician and a corrected report was subsequently issued.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics (ortho) inc.(b)(4).

• 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: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 7882133
• MDR Text Key: 120704548
• Report Number: 1319809-2018-00111
• 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: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Catalogue Number: 6802584
• Device Lot Number: 1515-377-8249
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 08/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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