MAUDE Adverse Event Report: AERSCHER DIAGNOSTICS HEMAPROMPT FG; REAGENT, OCCULT BLOOD

Model Number HPFG

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 02/25/2020

Event Type  malfunction  

Event Description

Hemaprompt testing area noted to already be tinted blue prior to specimen on area.Lot #159, 161.The remainder for lot #159, 161 removed from stock.Testing performed on different lot of hemaprompt testing strips.

• Brand Name: HEMAPROMPT FG
• Type of Device: REAGENT, OCCULT BLOOD
• Manufacturer (Section D): AERSCHER DIAGNOSTICS; 125 dixon drive; chestertown MD 21620
• MDR Report Key: 9817722
• MDR Text Key: 182955293
• Report Number: 9817722
• Device Sequence Number: 1
• Product Code: KHE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2020

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
• Device Operator: Health Professional
• Device Model Number: HPFG
• Device Lot Number: 159 / 161
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1