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

Catalog Number 8298671

Device Problem Low Readings (2460)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a lower than expected vitors phyt (phenytoin) result was obtained for a cap (college of american pathologists) proficiency sample, using vitros phyt slide lot 2618-0169-6448 on a vitros 5600 integrated system.The assignable cause of this event is user error due to an inappropriate interpretation of an analyzer condition code.The vitros 5600 integrated system did not generate a vitros phyt result of < 3.0 ug/ml for the sample, which was the value reported by the customer.An analyzer condition code occurred when the sample was initially run, and no phyt result was generated at that time.The customer then retested the cap sample chm-13 with a 2x dilution, and generated a result of <6.0 ug/ml.The customer did not report the vitros phyt result of <6.0 ug/ml, but reported <3.0 ug/ml, as they realized the vitros instrument had multiplied a phyt value of <3.0 ug/ml by the dilution factor of 2.Since the phenytoin concentration of the cap sample chm-04 was not above the vitros phyt measuring range of 3.0 ¿ 40 ug/ml, it is not appropriate to dilute the sample.The customer understood that the operator's interpretation of the condition code was incorrect, and that reporting vitros phyt value of < 3.0 ug/ml for the proficiency sample was inappropriate.Historical quality control results indicated that vitros phyt slide lot 2618-0169-6448 was performing as intended on the vitros 5600 integrated system j1399, and neither the vitros instrument or slide lot likely contributed to the event.Ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros phyt lot 2618-0169-6448.

Event Description

A customer obtained a lower than expected vitors phyt (phenytoin) result for a cap (college of american pathologists) proficiency sample, using vitros phyt slide lot 2618-0169-6448 on a vitros 5600 integrated system.Cap proficiency sample chm-04, vitros phyt result of <3.0 ug/ml versus expected vitros peer mean of 5.84 ug/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The lower than expected vitros phyt result was obtained when the customer was processing a non-patient, proficiency sample.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There was no allegation of actual patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4) and ivd (b)(4).

• 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: 8711407
• MDR Text Key: 213702992
• Report Number: 1319809-2019-00042
• 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: 06/19/2019

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: 06/15/2019
• Device Catalogue Number: 8298671
• Device Lot Number: 2618-0169-6448
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/22/2019
• Initial Date FDA Received: 06/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2019
• 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