MAUDE Adverse Event Report: ORTHO CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6802156

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that discordant, higher than expected vitros ntbnp results were obtained from a single patient sample when tested using vitros ntbnp lot#: 2170 on a vitros 5600 integrated system.The results were discordant when compared to the vitros ntbnp lot 2140 result from the same patient sample.The most likely cause of the discordant, higher than expected vitros ntbnp results is a patient sample issue, caused by a combination of hemolysis, fibrin and turbidity in the patient sample.The customer stated that the patient sample was visibly hemolyzed when the sample was observed following testing on (b)(6) 2019.Also, strands of fibrin were found in the patient sample when the sample was observed on 26 september 2019, indicating pre-analytical sample handling errors prior to testing.According to the turbidity index of the patient sample, the sample was more turbid on (b)(6) 2019 following storage in a fridge following testing on 25 september 2019.Pre-analytical sample processing could not be ruled out as a contributing factor as the customer is was not established whether the customer was following the sample collection device manufacture¿s recommendation for sample centrifugation.Improper pre-analytical sample handling could have contributed to this event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this could not be confirmed.A vitros ntbnp lot: 2170 reagent issue cannot be ruled out as a contributor to the event, as the higher than expected results were both obtained on lot: 2170, and the expected result was obtained on vitros ntbnp lot 2140.Additionally, limited quality control data was available to evaluate the performance of vitros ntbnp lot: 2170 leading up to the event, as the discordant results were obtained on the first day of use of vitros ntbnp lot: 2170, and the customer reverted to vitros ntbnp lot 2140 following the event.However, quality control results on the day of the event were within acceptable guidelines and ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros ntbnp reagent lot: 2170.An instrument issue is an unlikely contributor to the event, as precision testing on the vitros 5600 integrated system indicated that the instrument was performing as expected around the time of the event.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solution center (tsc) to report discordant, higher than expected vitros nt ¿ probnp (ntbnp) lot 2170 patient sample results when tested on a vitros 5600 integrated system.The results were discordant compared to the results from the same patient same tested using vitros ntbnp lot#: 2140.Vitros ntbnp lot 2170 results of 1333.08 pg/ml and 553.18 pg/ml versus vitros ntbnp lot#: 2140 result of 47.98 pg/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The higher than expected vitros ntbnp results were not reported from the laboratory.Ortho has not been made aware of any allegation of patient harm as a result of this event.This report corresponds to ortho clinical diagnostics inc.Complaint number (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS NT-PROBNP REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section G): ORTHO CLINICAL DIAGNOSTICS; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: james a stevens ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 9232719
• MDR Text Key: 219509839
• Report Number: 3007111389-2019-00167
• Device Sequence Number: 1
• Product Code: NBC
• 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: 10/24/2019

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: 01/04/2020
• Device Catalogue Number: 6802156
• Device Lot Number: 2170
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 09/26/2019
• Initial Date FDA Received: 10/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/17/2019
• 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