INVADER FACTOR II 95-452

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-01-11 for INVADER FACTOR II 95-452 manufactured by Hologic, Inc.

Event Text Entries

[96974909] (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.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2024800-2018-00003
• MDR Report Key: 7182084
• Report Source: HEALTH PROFESSIONAL
• Date Received: 2018-01-11
• Date of Report: 2018-01-11
• Date of Event: 2017-12-19
• Date Mfgr Received: 2017-12-19
• Date Added to Maude: 2018-01-11
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MS. JULIETTE BUSSE
• Manufacturer Street: 10210 GENETIC CENTER DR.
• Manufacturer City: SAN DIEGO CA 92121
• Manufacturer Country: US
• Manufacturer Postal: 92121
• Manufacturer Phone: 8584108799
• Manufacturer G1: HOLOGIC, INC.
• Manufacturer Street: 10210 GENETIC CENTER DR.
• Manufacturer City: SAN DIEGO CA 92121
• Manufacturer Country: US
• Manufacturer Postal Code: 92121
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: INVADER FACTOR II
• Generic Name: IN-VITRO DIAGNOSTICS
• Product Code: NPR
• Date Received: 2018-01-11
• Catalog Number: 95-452
• Lot Number: 191193
• Device Availability: *
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HOLOGIC, INC
• Manufacturer Address: 10210 GENENETIC CENTER DR. SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2018-01-11