MAUDE Adverse Event Report: HOLOGIC, INC INVADER FACTOR II; IN-VITRO DIAGNOSTICS

Catalog Number 95-452

Device Problems Improper or Incorrect Procedure or Method (2017); Incorrect Or Inadequate Test Results (2456)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/19/2017

Event Type  Injury  

Event Description

(b)(6), customer, had discrepant results for ten samples that were manually tested with the factor ii assay.The customer ran a factor ii assay on (b)(6) 2017 containing ten samples, two samples provided carrier/heterozygous (het) results, and eight samples provided negative/homozygous wild type (wt) results.The factor ii assay results from (b)(6) 2017 were questioned and the customer re-tested the original ten factor ii samples on (b)(6) 2017, and all results were wt.The customer stated that the discrepant results were likely caused by an operator error which impacted the original run performed on (b)(6) 2017.The customer frequently tests the factor v and factor ii assays concurrently, on the same assay plate, using the same samples; so the customer believes the factor v oligo mix was used for the factor ii assay.Although the factor v assay was likely performed using the incorrect oligo mix, the assay was valid.It was emphasized to customer that the factor ii and factor v controls are not interchangeable.The controls from the factor ii kit should be used with the factor ii reagents and same for the factor v controls and reagents.Hologic evaluated this issue and determined that factor v and factor ii assay controls do contain a mixture of both targets, but they are filled separately and labeled individually for each assay.Because of this, the assay controls should not be used interchangeably for both assays.When a factor v or factor ii assay is performed, a reaction mix is prepared using a universal buffer, universal enzyme mix, and an assay-specific oligo mix.The assay controls are intended to ensure that proper amplification occurs, but they do not control for severe operator errors such as preparing the factor ii reaction mix using the factor v oligo mix.Per hologic's risk assessment, the customer performed factor ii testing with factor v oligo mix, resulting in incorrect results.The severity associated with incorrect result is serious but the probability of incorrect results is remote.The final risk is assessed as far as possible.

• Brand Name: INVADER FACTOR II
• Type of Device: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC, INC; 10210 genenetic center dr.; san diego CA 92121
• Manufacturer (Section G): HOLOGIC, INC.; 10210 genetic center dr.; san diego CA 92121
• Manufacturer Contact: juliette busse ; 10210 genetic center dr.; san diego, CA 92121 ; 8584108799
• MDR Report Key: 7182084
• MDR Text Key: 96974909
• Report Number: 2024800-2018-00003
• Device Sequence Number: 1
• Product Code: NPR
• UDI-Device Identifier: 15420045506558
• UDI-Public: 15420045506558
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100943
• 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: 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: 95-452
• Device Lot Number: 191193
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other