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 04/04/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation determined that higher than expected vitros bhcg results were obtained from non vitros biorad l1 qc fluid using vitros immunodiagnostics product total b-hcg ii (bhcg) reagent on a vitros 5600 integrated system.The assignable cause for the higher than expected vitros bhcg results could not be determined with the information provided.Based on historical quality control results, a vitros bhcg lot 2310 performance issue is not a likely contributor to the event.Additionally, there is also 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.Continual tracking and trending of complaints has not identified any signals that would indicate a potential systematic issue with vitros bhcg ii reagent lot 2310.The higher than expected vitros bhcg qc fluid results were from non-patient fluids and so were not reported from the laboratory.However, the investigation could not conclude patient samples were not affected or would not be affected if the event were to recur undetected.There is no allegation of patient harm as a result of the event.

Event Description

A customer obtained higher than expected total -hcg (bhcg) results from obtained from non-vitros biorad quality control (qc) fluid using vitros immunodiagnostics product total b-hcg ii (bhcg) reagent on a vitros 5600 integrated system.Br l1 qc fluid result of 11.48 miu/ml vs.Expected result of 3.57 miu/ml.Biased results of the magnitude and direction observed may lead to inappropriate physician action if they were to occur undetected.The result stemmed from a qc fluid, however, the investigation could not confirm that patient samples would not be affected if the event were to recur undetected.There was no allegation of patient harm as a result of the 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: 8581975
• MDR Text Key: 203705937
• Report Number: 3007111389-2019-00081
• Device Sequence Number: 1
• Product Code: DHA
• 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: 05/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/21/2019
• Device Catalogue Number: 6802220
• Device Lot Number: 2310
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/09/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/17/2018
• 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