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 Test Results (2457)

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

Event Date 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected bhcg ii results were obtained from non-vitros seronorm l1 qc fluid lot 1709896 using vitros immunodiagnostics products bhcg ii reagent lot 2680 in combination with a vitros 5600 integrated system.The assignable cause for the higher than expected vitros bhcg qc fluid results could not be determined with the information provided.Based on historical quality control results, a vitros bhcg lot 2680 performance issue is not a likely contributor to the event.Additionally, there is no indication of an instrument malfunction and unexpected instrument performance is not a likely contributor to the events as precision testing performed on the instrument was within ortho guidelines.Sample handling could not be ruled out as a possible cause of the higher than expected results as the customer was only allowing 5 minutes before loading on the instrument following removal from the refrigerator per the vitros bhcg instructions for use, you should bring samples to room temperature 15¿30 °c (59¿86 °f) before use.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systemic issue with vitros bhcg ii reagent lot 2680.

Event Description

A customer contacted the ortho clinical diagnostics (ortho) technical solutions center (tsc) to report higher than expected bhcg ii results obtained from a non-vitros seronorm l1 quality control (qc) fluid, using vitros immunodiagnostics product total b-hcg ii (bhcg) reagent on a vitros 5600 integrated system.Seronorm l1 qc fluid lot 1709896: 12.09 and 9.09 miu/ml versus expected result of 6.00 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 bhcg results were from non-patient fluid.The customer did not give any indication that patient results had been affected.However, the investigation cannot conclude that patient sample results would not be affected if the event were to recur undetected.There is no allegation of patient harm as a result of this event.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.(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: 10477588
• MDR Text Key: 233927115
• Report Number: 3007111389-2020-00117
• Device Sequence Number: 1
• Product Code: DHA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/01/2020

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: 02/09/2021
• Device Catalogue Number: 6802220
• Device Lot Number: 2680
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 09/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2020
• 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