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

Model Number 8000-06958

Device Problem High Readings (2459)

Patient Problem Hypoglycemia (1912)

Event Date 07/24/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, a (b)(6) year old male consumer reported that he experienced hypoglycemia, but the meter was giving him false high readings.He stated this morning that the ibgstar meter measured his blood glucose to be 5.8 mmol/l.He felt dizzy and was convinced he was experiencing hypoglycemia.He decided to test with his one touch meter.That measured his blood-glucose to be 2.8 mmol/l.He is taking lantus (insulin glargine) 40 units daily and novorapid (insulin aspart) on a sliding scale.He tried a control solution set, which fell within range.

Manufacturer Narrative

The device has been returned to the mfr and is pending investigation.The meter dhr was referenced.The meter was released from the factory within specification.No test strip lot info was provided.The owner's manual was carefully reviewed.There is no indication the event occurred due to poor labeling.An analysis of field returns regarding ibgstar meters and similar complaints shows no accuracy issues attributed to meter malfunction have been confirmed.Based on the limited info provided, the root cause of the incident cannot be determined.This complaint will 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 inc; salem, NH 03079 ; 6033286000
• MDR Report Key: 4058852
• MDR Text Key: 4904679
• Report Number: 3004637226-2014-00027
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• 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

• Date FDA Received: 08/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 8000-06958
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR