MAUDE Adverse Event Report: ORTHO-CLINICAL DIAGNOSTICS VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK; IN VITRO DIAGNOSTICS

Catalog Number 6802220

Device Problem High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/09/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected vitros b-hcg result was obtained from a patient sample when tested using vitros b-hcg lot 2610 on a vitros eci immunodiagnostic system.The vitros b-hcg result was higher than expected when compared to negative vitros b-hcg results from the same patient.A definitive cause of the event was not established.However, an instrument issue is the most probable contributor to the event.It was established that the customer was not performing maintenance actions on the instrument correctly and crystallization was detected on signal reagent and well wash metering probes by the ortho ls.Precision tests on the instrument indicating acceptable performance following the event, however, the performance of the instrument was not verified with a precision test around the time of the event.A vitros b-hcg lot 2610 reagent issue cannot be ruled out as a contributor to the event, as no quality control data was available to verify reagent performance.However, ongoing tracking and trending of complaint data has not identified any signals to suggest there is a systemic quality issue with vitros b-hcg lot 2610.In addition, pre-analytical sample processing could not be ruled out as a contributing factor as the customer was not following the sample collection device manufacturer¿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.

Event Description

An ortho clinical diagnostics (ortho) laboratory specialist (ls) contacted the ortho technical solution center (tsc) on behalf of a customer to report a higher than expected bhcg ii result obtained from a single patient sample when tested using vitros immunodiagnostics products -hcg ii (b-hcg) reagent pack in combination with a vitros eci immunodiagnostic system.The vitros b-hcg result was higher than expected when compared to negative vitros b-hcg results obtained on a vitros system at another customer site.Vitros b-hcg result of 6100.4 miu/ml versus the expected result of 2.39 miu/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 b-hcg result was reported from the laboratory.The outcome of the reported result was for repeat testing to be performed at another facility, which resulted as expected.No treatment was altered, initiated or stopped based on the reported result and 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 TOTAL B HCG II REAGENT PACK
• Type of Device: IN VITRO DIAGNOSTICS
• Manufacturer (Section D): ORTHO-CLINICAL DIAGNOSTICS; 100 indigo creek drive; rochester NY 14626
• 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: 10418708
• MDR Text Key: 245926220
• Report Number: 3007111389-2020-00098
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: CI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2020
• Device Catalogue Number: 6802220
• Device Lot Number: 2610
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/07/2020
• 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