MAUDE Adverse Event Report: AKERS BIOSCIENCES, INC. PIFA HEPARIN/PF4 RAPID ASSAY

Catalog Number 4036025

Device Problem Insufficient Information (3190)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

Mw5087039 was reported to medwatch on (b)(6) 2019.We received it on june 12, 2019 and began trying to contact the reporter starting on (b)(4) 2019.On (b)(4) 2019, after 2 attempts,we finally spoke with dr (b)(6) who reported that both mw5087039 & mw5087059 medwatch reports were reported by her on the same day.Each report was about a separate incident & she reported them because she "just didn't want to have any hippa violations and that we should really talk to the lab because they are knowledgeable about these things and she was on leave at the time".The dr.Declined to give us any contact information for the lab except the location.We attempted contact with the facility 6 times from (b)(4) - (b)(4) 2019.We spoke with several staff members at (b)(6) medical center on (b)(6) 2019.They were reluctant to give out any information because they did not want to violate hippa regulations.When asked if a patient had been harmed or died they said that they could not answer that.When asked for dates that the incident happened they could not answer that except that it had occurred in the month of (b)(6) 2018.They said they would forward any info they had but did not think they could give us a lot of information because of hippa regulations.We were never contacted by the facility or the doctor to report an incident or to ask for technical support during 2018 or 2019.We received information 7/26/2019 suggesting injury to a patient, prompting this report.

Event Description

Unknown.

Event Description

As the manufacturer, our quality department attempted to contact both the initial reporter and the end user facility.After several attempts we were able to contact each of them but were not able to gather much information about the adverse event.Both the initial reporter and the end user facility stated hippa as the reason they would not discuss the adverse event.Subsequent to this our company was advised through legal counsel that a female patient had a foot or lower left leg amputated after a knee replacement surgery.

• Brand Name: PIFA HEPARIN/PF4 RAPID ASSAY
• Type of Device: PIFA HEPARIN/PF4 RAPID ASSAY
• Manufacturer (Section D): AKERS BIOSCIENCES, INC.; 201 grove road; thorofare NJ 08050
• Manufacturer Contact: jennifer lelinski ; 201 grove rd; thorofare, NJ 08086 ; 8568488698
• MDR Report Key: 9166290
• MDR Text Key: 172922747
• Report Number: 2247413-2019-00001
• Device Sequence Number: 1
• Product Code: LCO
• Combination Product (y/n): N
• PMA/PMN Number: K040293
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 4036025
• Device Lot Number: 24298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability