MAUDE Adverse Event Report: FORA CARE INC. FORA GD20 BLOOD GLUCOSE METER; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Model Number	GD20FM01-BLK
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The glucometer had normal readings when testing with the control solution, however, when testing on a patient, the results were very high.Our initial reading was 589.The hospital tested the patient blood glucose with their machine and got 113.We did a retest with the blood from the same finger stick on our machine and got a secondary reading of 167.The hospital did a retest and got 112.

• Brand Name: FORA GD20 BLOOD GLUCOSE METER
• Common Device Name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): FORA CARE INC.
• MDR Report Key: 18059500
• Report Number: MW5147665
• Device Sequence Number: 7684281
• Product Code: NBW
• UDI-Device Identifier: 00816042010804
• UDI-Public: 00816042010804
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/17/2023

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
• Operator of Device: Health Professional
• Device Model Number: GD20FM01-BLK
• Device Lot Number: 321-4251400-009
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2023
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 127 KG