MAUDE Adverse Event Report: AGAMATRIX INC. IBGSTAR BGMS; BLOOD GLUCOSE METER

Model Number 8000-05716

Device Problem High Readings (2459)

Patient Problem Hypoglycemia (1912)

Event Date 08/05/2014

Event Type  Injury  

Event Description

The patient had been (b)(6) pregnant at the time of the event.She was diagnosed with type 2 diabetes six years ago and had been managing with oral medication.She was switched to humalog with an insulin pump at the beginning of the pregnancy.For the past two or three days, the patient has experienced three episodes in which hypoglycemic symptoms (shaking, sweating, fatigue) were present, but her ibgstar meter was measuring her blood-glucose between 0.7 and 1.5 g/l.She felt these readings were not indicative with how she felt.A control solution test, which was performed at a pharmacy, was within range.The patient suspects the pregnancy as a cause of the onset of events.Patient ate some food and has since been feeling well.

Manufacturer Narrative

The device was requested, but has not been returned to the mfr.The meter dhr has been reviewed and was released from the factory within specification.No test strip lot info was provided.The owner's guide has been carefully reviewed.There is no indication the even occurred due to poor labeling.Ibgstar field returns regarding similar complains have been reviewed.There is no evidence the event occurred due to a component failure.A control solution test was performed at a pharmacy and the result was within range.Insulin may have contributed to the event.Taking the frequency of hypoglycemic events (three times in 2-3 days) into account, it is possible the patient's dosage scale may be incorrect.The patient believes her pregnancy is the cause for the onset of the symptoms, no the accuracy of the meter.This event will continue to be trended.

• Brand Name: IBGSTAR BGMS
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): AGAMATRIX INC.; 7c raymond ave; salem NH 03079
• Manufacturer Contact: david olsen ; 7c raymond ave; salem, NH 03079 ; 6033286000
• MDR Report Key: 4058865
• MDR Text Key: 4730932
• Report Number: 3004637226-2014-00028
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K103544
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/19/2014

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
• Device Operator: Other
• Device Model Number: 8000-05716
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2014
• Initial Date FDA Received: 08/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 105