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

Catalog Number 8298671

Device Problem Low Test Results (2458)

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

Event Date 05/04/2017

Event Type  malfunction  

Manufacturer Narrative

The investigation confirmed that six lower than expected vitros phyt results were obtained from four samples collected from the same patient that were processed using two different vitros phyt slide lots on a vitros 5600 integrated system.User error related to pre-analytical sample handling is the most likely assignable cause.The customer is not following the manufacturer recommendations for centrifuge spin time.It is likely that cellular debris, due to poor sample preparation, was present in the affected samples, although this could not be confirmed.Acceptable performance was obtained when the manufacturer recommendations for centrifuge spin time were used.A vitros crbm within-run precision test (used to assess instrument performance) was performed on the vitros 5600 instrument and the results were within acceptance criteria.This indicates the vitros 5600 instrument was performing as intended and did not likely contribute to the event.Since two different vitros phyt slide lots were affected, it is unlikely a vitros phyt slide related issue contributed to the event.

Event Description

The customer observed six lower than expected vitros phyt results that were obtained from four different samples collected from the same patient using two different slide lots of vitros phyt slides on a vitros 5600 integrated system.Phyt lot 2614-0162-8538: plasma patient sample #1 result = 3.4 ug/ml versus an expected result of 8.5 ug/ml.Phyt lot 2615-0163-9699: plasma patient sample #2 result = 4.9, 5.1 ug/ml versus an expected result of 9.6 ug/ml.Plasma patient sample #3 result = 4.0, 5.8 ug/ml versus an expected result of 11.6 ug/ml.Plasma patient sample #4 result = 8.6 ug/ml versus an expected result of 12.0 ug/ml.Biased patient results of the direction and magnitude observed may lead to inappropriate physician action if occurred undetected.The lower than expected patient result of 3.4 ug/ml was initially reported from the laboratory and questioned by a physician and a corrected report was issued.The lower than expected result of 4.9 ug/ml was reported outside of the laboratory.No other results were reported outside of the laboratory.There was no allegation of patient harm.This report is number 2 of 2 mdr¿s for this event.Two (2) 3500a forms are being submitted for this event as 2 devices were involved.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4) and 1928835/ivd 412051.

• Brand Name: VITROS CHEMISTRY PRODUCTS PHYT 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: 6829685
• MDR Text Key: 86283931
• Report Number: 1319809-2017-00163
• Device Sequence Number: 1
• Product Code: DIP
• 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: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Catalogue Number: 8298671
• Device Lot Number: 2614-0162-8538
• Other Device ID Number: 10758750004690
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2017
• 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