MAUDE Adverse Event Report: AGAMATRIX, INC. ONE DROP CHROME BGMS; BLOOD GLUCOSE METER

Model Number	8000-10465
Medical Device Problem Code	High Test Results (2457)
Health Effect - Clinical Code	Hypoglycemia (1912)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was requested but has not been returned to the manufacturer.The meter dhr was referenced and the meter left the manufacturer within specification.The reported test strip lot dhr was referenced and the lot cleared qc for release.The owner's guide and previous field returns have been reviewed.There is no evidence the event was caused by improper labeling.There is no evidence from previous field returns the event was caused by a meter malfunction.Based on the information provided, the root cause of the event could not be determined though insulin, other medication, diet and exercise may have been a cause.Factors such as hematocrit, temperature, humidity, elevation, and testing procedure may have contributed to the discrepant readings.No corrective action will be performed because no system error can be confirmed.This event will continue to be trended.
Event or Problem Description
Patient called in because the one drop chrome meter is showing readings that are higher than usual for him, even when he has symptoms of low blood glucose.Additionally, the one drop chrome is reported to measure blood-glucose 20-50 mg/dl higher than his embrace pro.He measures his blood-glucose 4-7 times and injects about 40 units of insulin per day.The night previous to calling, he felt like his blood-glucose was getting low so he measured with his one drop chrome (75 mg/dl) but reported never experiencing symptoms of hypoglycemia at 75 mg/dl.His symptoms worsened so he checked with his embrace pro (35 mg/dl).This measurement was reported to occur 5-10 minutes after the first.There is no indication that medical personnel were required to stabilize his blood-sugar.No information was provided on whether insulin was administered in response to a one drop chrome measurement prior to the event, and if so, neither the measurement value nor the dosage was provided.

• Brand Name: ONE DROP CHROME BGMS
• Common Device Name: BLOOD GLUCOSE METER
• Manufacturer (Section D): AGAMATRIX, INC.; 7c raymond ave; salem NH 03079
• MDR Report Key: 7041269
• Report Number: 3004637226-2017-00013
• Device Sequence Number: 977441
• Product Code: NBW
• UDI-Device Identifier: 00859509006019
• UDI-Public: (01)00859509006019
• Combination Product (Y/N): N
• PMA/510(K) Number: K161834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 8000-10465
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/17/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other