IBGSTAR BGMS

MDR report key: 2903467 · Received January 4, 2013

Report

Report Number: 3004637226-2013-00001
Event Type: Injury
Date Received: January 4, 2013
Date of Event: December 7, 2012
Report Date: January 4, 2013
Manufacturer: AGAMATRIX, INC.
Product Code: NBW
PMA / PMN Number: K103544
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METER WAS NOT RETURNED FOR EVALUATION.

Description of Event or Problem · 1

THE CUSTOMER COMPARED HIS IBGSTAR METER READINGS WITH THE FREESTYLE LITE. RESULTS OF THE IBGSTAR CONSISTENTLY SHOW 4-5 MMOL/L ABOVE THIS DEVICE. ON ONE TEST HE USED IBGSTAR WHICH READ 8.9 MMOL/L. HE CORRECTED HIS INSULIN BY 2 UNITS, 20 MIN. LATER HE TESTED HIS FREESTYLE LITE WHICH SHOWED 2.9 MMOL. HE STATES THAT HE USUALLY GETS SYMPTOMS WHEN HE IS HIGH OR LOW AND THAT HE DID NOT FEEL SYMPTOMATIC AT THE 8.9 BUT DID AT 2.9.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
4964	IBGSTAR BGMS	BLOOD GLUCOSE METER	NBW	AGAMATRIX, INC.	8000-08131

Patients

Seq	Age	Sex	Outcome	Treatment
1	UNKNOWN		Other