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

Model Number	HPFG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
All boxes of hemaprompt fg guaiac cards in ed with lot number 307 (which is our current only supply) have had numerous faulty testing cards.Control area is not developing therefore rendering the test faulty and unusable.Has been requiring utilization of multiple cards per patient specimen to find one in batch that does pass control.

• Brand Name: HEMAPROMPT FG
• Common Device Name: REAGENT, OCCULT BLOOD
• Manufacturer (Section D): AERSCHER DIAGNOSTICS; 125 dixon drive; chestertown MD 21620
• MDR Report Key: 25183494
• Report Number: 25183494
• Device Sequence Number: 13425153
• Product Code: KHE
• UDI-Device Identifier: 00693501000152
• UDI-Public: (01)00693501000152
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/05/2026
• Report Date (Section F): 05/05/2026

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 Model Number: HPFG
• Device Lot Number: 307
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/15/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 05/05/2026