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

Catalog Number 6802220

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that a higher than expected b-hcg ii (bhcg) result was obtained when a single patient sample was tested using vitros bhcg lot 2860 on a vitros 5600 integrated system.The assignable cause for the higher than expected vitros bhcg result could not be determined.As this was a new lot four days prior to the higher than expected result being obtained, there was not sufficient historical quality control results to draw a conclusion of performance prior to the event.However, current qc performance in combination with vitros bhcg lot 2860 is acceptable.A vitros bhcg lot 2860 performance issue is not a likely contributor to the event.Additionally, an ortho service engineer determined that the microwell subsystem including the luminometer, well wash, signal reagent, and dispense profiles were all as expected.There is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the event.However, an instrument issue at the time of the event cannot be completely ruled out as no diagnostic precision testing was performed.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg reagent lot 2860.The customer did not provide their pre-analytical sample handling process for either of the samples.Therefore, improper sample processing (sample centrifugation) cannot be ruled out as a contributor to the event.It is possible that cellular debris, due to poor sample preparation, was present in the affected sample, although this cannot be confirmed.Email address for contact office in field (b)(4).

Event Description

A customer obtained a higher than expected b-hcg ii (bhcg) result when a single patient sample was tested using vitros bhcg lot 2860 on a vitros 5600 integrated system.Vitros bhcg patient sample 1 result of 69.59 miu/ml vs the expected result of <2.39 miu/ml.Biased results of the direction and magnitude observed may lead to inappropriate physician action if undetected.The non-reproducible, higher than expected, vitros bhcg result was reported from the laboratory but a corrected report was issued.There was no allegation of actual patient harm as a result of the event.This report corresponds to ortho clinical diagnostics inc (ortho).Complaint numbers (b)(4).

• Brand Name: VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B HCG II REAGENT PACK
• 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; felindre meadows; pencoed; bridgend, wales CF35 5PZ; UK CF35 5PZ
• Manufacturer Contact: laurie o'riordan ; 100 indigo creek drive; rochester, NY 14626 ; 5854533000
• MDR Report Key: 11536824
• MDR Text Key: 242526714
• Report Number: 3007111389-2021-00039
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: KU
• 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: 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/07/2021
• Device Catalogue Number: 6802220
• Device Lot Number: 2860
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2020
• 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