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

Catalog Number	95-452
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/19/2017
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: IN-VITRO DIAGNOSTICS
• Manufacturer (Section D): HOLOGIC, INC; 10210 genenetic center dr.; san diego CA 92121
• MDR Report Key: 7182084
• Report Number: 2024800-2018-00003
• Device Sequence Number: 13700060
• Product Code: NPR
• UDI-Device Identifier: 15420045506558
• UDI-Public: 15420045506558
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K100943
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

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