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

Model Number 8000-10291

Device Problems High Test Results (2457); Low Test Results (2458)

Patient Problem Neuropathy (1983)

Event Date 09/23/2017

Event Type  Injury  

Manufacturer Narrative

The device was requested but has not been returned to the manufacturer.The meter dhr has been referenced and the meter left the factory within specification.The test strip lot (nu10wp84l, exp 04/30/2018 dhr was referenced and the lot cleared qc for release.This is the first accuracy complaint for this lot.The owner's guide and previous field returns have been reviewed.The complaint describes the patient starting use of the cvs advanced meter four months prior to the amputation.Neuropathy requiring amputation typically does not set in within 4 months.In order for the meter to be the cause of the neuropathy, one would expect it to consistently measure the patient's blood sugar lower than the actual value.The complaint description does not support this as the meter was reported to read both high and low.Examples with comparisons to a stat strip meter are provided that show the cvs advanced meter measuring above and below that of the hospital's.If a meter were to display blood-glucose measurements too high, a patient trying to control his blood-sugar would like experience more symptoms of hypoglycemia, not elevated blood-sugar.There is no evidence from previous field returns, or the above description, the event was caused by a meter malfunction.Based on the information provided, the root cause of the high or low values compared to the hospital's device cannot be determined.Environmental factors, medical conditions, and testing practices, could have contributed.No corrective action will be performed as system failure could not be confirmed.This complaint will continue to be trended.

Event Description

Customer called in alleging the cvs advanced meter was measuring his blood-glucose incorrectly and contributed to the necessity of amputating his toe.He had meter for about 4 months and claims that the readings have been consistently too high the whole time he had the meter.He is in the hospital right now and got his toe amputated on saturday.Stated that this meter is the reason he lost his toe.While on the phone the nurse took a blood test with their bgm (stat strip) and got 117 mg/dl.Took a test with the cvs advanced meter with the same drop of blood and received 142 mg/dl.Additional information received on follow-up: doctor told him one of the biggest reasons he had his toe amputated was because the meter was giving him incorrect readings (he said too high and too low) they did numerous comparison tests in the hospital and one example was hospital meter got 170 and cvs was 100 within a 10-15 min period.

• Brand Name: JAZZ CVS BGMS
• Type of Device: BLOOD GLUCOSE METER
• Manufacturer (Section D): AGAMATRIX, INC.; 7c raymond ave; salem NH 03079
• Manufacturer (Section G): AGAMATRIX, INC.; 7c raymond ave; salem NH 03079
• Manufacturer Contact: david olsen ; 7c raymond ave; salem, NH 03079
• MDR Report Key: 6951596
• MDR Text Key: 89382653
• Report Number: 3004637226-2017-00011
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K072413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 10/16/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: 8000-10291
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/16/2017
• Date Device Manufactured: 11/24/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other