MAUDE Adverse Event Report: AGAMATRIX, INC. JAZZ BGMS; BLOOD GLUCOSE MEETER

Model Number 8000-02345

Device Problem High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Date 02/02/2014

Event Type  malfunction  

Event Description

The reporter alleges the jazz meter was inaccurately measuring her blood-glucose high.As a result, she adjusted her insulin and experienced hypoglycemia.The pt measured her blood-glucose before eating at 12:47 pm and the jazz meter read 22.4 mmol/l.She adjusted her insulin as well as her carbohydrate intake (she ate her sandwich but not her yogurt).After lunch she describes feeling hypoglycemic at 2:24 pm.A blood-glucose measurement was performed and the meter read 25.7 mmol/l.She did not feel this was correct and took juice and a biscuit.Her blood-glucose was tested again eleven minutes later and the meter read 6.1 mmol/l.

Manufacturer Narrative

The meter has been requested and has been returned to the (b)(6) office.The meter is currently being returned to the main office.The meter dhr shows the meter left the factory within specification.The test strip lot dhr review shows the lot cleared qc for release.At a later time, follow-up calls prompted three consecutive blood tests on capillary whole blood (11.6, 11.3, 11.8 mmol/l).The reporter also performed control solution tests with normal and high control solution in triplicate (normal control solution readings: 7.5, 7.4, 7.3, range 5.8-8.9 mmol./l, high control solution readings: 20.0, 19.1, 19.9, range 14.9-22.4 mmol/l); all results were within range.During a face-to-face meeting with the reporter, historic data was downloaded, but the meter was retained by the reporter to be returned at a later time.The data contains a large number of readings (approx 20%) that fall within the hypoglycemic (<3.9 mmol/l) or hyperglycemic (>13.3 mmol/l) ranges.This indicates the user may not have the best control of her diabetes.The instructions for use direct the user to perform a second measurement if she feels the first is inaccurate.There was no indication this was performed.The meeting also showed that while she had 50+ years experience as a diabetic, proper testing technique, specifically washing hands before a test, may not have been habitual as noted by a representative from medicines management who sat in on the meeting.Since all control solution testing was found to be within range, and a second test was not performed, improper testing technique or contamination are the most likely contributors to the consecutive inaccurate high readings.

• Brand Name: JAZZ BGMS
• Type of Device: BLOOD GLUCOSE MEETER
• Manufacturer (Section D): AGAMATRIX, INC.; 7c raymond avenue; salem NH 03079
• Manufacturer Contact: david olsen ; 7c raymond avenue; salem, NH 03079
• MDR Report Key: 4563269
• MDR Text Key: 5551216
• Report Number: 3004637226-2015-00003
• Device Sequence Number: 1
• Product Code: JJX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K072413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2015

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: Lay User/Patient
• Device Expiration Date: 02/29/2016
• Device Model Number: 8000-02345
• Device Lot Number: LA17WA64M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2012
• 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