MAUDE Adverse Event Report: AKERS BIOSCIENCES, INC. AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING; PLATELET FACTOR 4 RADIOIMMUNOASSAY

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Type  Injury  

Event Description

Akers bioscience pifa anti pf4 hit antibody testing came back negative, which delayed the diagnosis of the rare spontaneous hit, repeat was alos negative, but later hit elisa and sra was positive.Fda safety report id# (b)(4).

• Brand Name: AKERS BIOSCIENCES RAPID PIFA HIT ALO TESTING
• Type of Device: PLATELET FACTOR 4 RADIOIMMUNOASSAY
• Manufacturer (Section D): AKERS BIOSCIENCES, INC.
• MDR Report Key: 8658542
• MDR Text Key: 146902505
• Report Number: MW5087039
• Device Sequence Number: 1
• Product Code: LCO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/27/2019

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 70 YR