MAUDE Adverse Event Report: PINNACLE LABS PSA HOME MICRO PROSTATE CANCER TEST; PROSTATE SPECIFIC ANTIGEN

Device Problem Defective Device (2588)

Patient Problem Tissue Damage (2104)

Event Date 09/02/2017

Event Type  malfunction  

Event Description

Used pinnacle biolabs med device to take at home psa test.The device to puncture the skin was defective, reached out 3 times in as many weeks to customer service contact info, received no reply.

• Brand Name: PSA HOME MICRO PROSTATE CANCER TEST
• Type of Device: PROSTATE SPECIFIC ANTIGEN
• Manufacturer (Section D): PINNACLE LABS
• MDR Report Key: 6893985
• MDR Text Key: 87481662
• Report Number: MW5072427
• Device Sequence Number: 1
• Product Code: LTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Weight: 84