MAUDE Adverse Event Report: HOLOGIC, INC. CF INPLEX ASR CARD; ANALYTE SPECIFIC REAGENT

Model Number	95-0501
Medical Device Problem Codes	False Positive Result (1227); Nonstandard Device (1420)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2016
Type of Reportable Event	Malfunction
Event or Problem Description
Customers have experienced false positive results while testing patient samples using a cf inplex asr card.The customer received false positive het for s549r a>c.False positive results were repeated and came up negative for s549r a>c.Hologic voluntarily recalled this product on 4/1/2016 with a report of corrections and removals.

• Brand Name: CF INPLEX ASR CARD
• Common Device Name: ANALYTE SPECIFIC REAGENT
• Manufacturer (Section D): HOLOGIC, INC.; 10210 genetic center drive; san diego CA 92121
• MDR Report Key: 5588594
• Report Number: 2024800-2016-00014
• Device Sequence Number: 37223
• Product Code: MVU
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/19/2016

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
• Operator of Device: No Information
• Device Model Number: 95-0501
• Device Catalogue Number: 95-0501
• Device Lot Number: U35AV AND U34AE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2016
• Initial Report FDA Received Date: 04/20/2016
• 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: Life Threatening