MAUDE Adverse Event Report: AKERS BIOSCIENCE, INC. AKERS RAPID HIT AB PIFA TEST ; PLATELET FACTOR 4 RADIO IMMUNOASSAY

Device Problem False Negative Result (1225)

Patient Problem Test Result (2695)

Event Type  Injury  

Event Description

Hit ab testing done using akers bio science hit ab test was negative, which delayed the diagnosis of hit and hit elisa ab sent out side came back positive along with sra testing.Fda safety report id # (b)(4).

• Brand Name: AKERS RAPID HIT AB PIFA TEST
• Type of Device: PLATELET FACTOR 4 RADIO IMMUNOASSAY
• Manufacturer (Section D): AKERS BIOSCIENCE, INC.
• MDR Report Key: 8659260
• MDR Text Key: 146902601
• Report Number: MW5087059
• 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

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Disability
• Patient Age: 75 YR