PRESTO BGM

Report

Report Number: 3004637226-2014-00018
Event Type: Injury
Date Received: May 2, 2014
Date of Event: April 4, 2014
Report Date: May 1, 2014
Manufacturer: AGAMATRIX, INC
Product Code: NBW
PMA / PMN Number: K073573
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: DA
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICES HAVE NOT BEEN RETURNED TO THE MANUFACTURER. NO TEST STRIP LOT INFORMATION WAS PROVIDED. METER DHR FOR THE COMPLETE SERIAL NUMBER SHOWED IT LEFT THE FACTORY OPERATIONAL. AGAMATRIX HAS BEEN UNABLE TO GAIN THE COMPLETE SERIAL NUMBER OF THE SECOND METER. AGAMATRIX HAS BEEN UNABLE TO OBTAIN MORE INFORMATION ON THE INCIDENT. BASED ON THE LIMITED INFORMATION PROVIDED, THE ROOT CAUSE OF THE INCIDENT COULD NOT BE DETERMINED. THE OWNER'S GUIDE AND PREVIOUS FIELD RETURNS HAVE BEEN REVIEWED. THE EVENT WILL CONTINUE TO BE TRENDED.

Description of Event or Problem · 1

PATIENT WAS EXPERIENCING SIGNS OF HYPOGLYCEMIA (CONFUSED, CLAMMY SKIN) AND AMBULANCE WAS CALLED. RESPONDERS MEASURED BLOOD-GLUCOSE TO BE 2.9 MMOL/L AND ADMINISTERED 18G HYPOFIT AND SODA. RESPONDERS MEASURED BLOOD-GLUCOSE FIVE MINUTES LATER WITH A RESULT OF 9.1 MMOL/L. THE PATIENT'S SYMPTOMS WERE UNCHANGED AND ANOTHER MEASUREMENT WAS MADE (6.1 MMOL/L). PATIENT WAS MOVED TO THE AMBULANCE AND WAS MEASURED WITH A 2ND METER. IT READ 2.6 MMOL/L. ONE (1) MG OF GLUCAGON WAS ADMINISTERED AND THE PATIENT'S BLOOD-GLUCOSE MEASURED 3.6 MMOL/L AND 20 MINUTES LATER, 7.6 MMOL/L. BASED ON THE EVENT, THE RESPONDERS DECIDED TO TEST THE DEVICES ON THE SAME DROP OF BLOOD. THE 1ST READ 4.8 MMOL/L AND THE 2ND READ 6.1 MMOL/L. CONTROL SOLUTION TESTING WAS THEN CONDUCTED AND THEY RECEIVED FOUR DIFFERENT VALUES. THE RANGE, 6.9 MMOL/L TO 8.2 MMOL/L, IS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
264064	PRESTO BGM	BLOOD GLUCOSE METER	NBW	AGAMATRIX, INC	8000-02661

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other