FDA Adverse Event Malfunction Summary report: N

ASSURE PLATINUM BLOOD GLUCOSE SYSTEM

MDR report key: 3851700 · Received June 5, 2014

Report

Report Number: 1832816-2014-00046
Event Type: Malfunction
Date Received: June 5, 2014
Date of Event: May 11, 2014
Report Date: June 5, 2014
Manufacturer: ARKRAY, INC.
Product Code: NBW
PMA / PMN Number: K092104
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. ACTUAL PRODUCT WAS NOT RETURNED FOR TESTING. RETENTION SAMPLES OF THE SAME LOT OF TEST STRIPS INVOLVED IN THE INCIDENT WERE TESTED AND PERFORMED TO SPECIFICATION. CUSTOMER DID NOT RETURN PRODUCT

Description of Event or Problem · 1

CALLER INDICATED THE ASSURE PLATINUM METER WAS PRODUCING VARIABLE READINGS. THE NURSE CHECKED THE PATIENT'S BLOOD SUGAR USING FOUR DIFFERENT METERS. SHE RECEIVED READINGS OF HI, 45, 123, 156, 69 USING TWO METERS AND THEN 10 MINUTES LATER SHE TESTED WITH TWO OTHER METERS AND RECEIVED 42 AND 43 WHICH MATCHED HER SYMPTOMS. SHE WAS PALE, COOL, AND CLAMMY AND STARTED SWEATING AFTER THE 5TH TEST. THE CALLER FEELS THE FIRST TWO METERS USED WHERE NOT ACCURATE DUE TO THE FLUCTUATION IN READINGS. THEY ARE USING THE CORRECT TESTING TECHNIQUE FOR EACH TEST. THEY CLEANED THE PATIENT'S FINGERTIP WITH ALCOHOL MAKING SURE THAT IT WAS DRY BEFORE POKING. THE PATIENT IS NOT ON OXYGEN THERAPY AND HAS NO CHANGES IN MEDICATION OR STRESS. THE PATIENT WAS NOT TREATED BASED ON METER READINGS BUT WAS TREATED FOR LOW BLOOD SUGAR BECAUSE OF HER SYMPTOMS. CONTROLS USED WERE IN RANGE. REPLACING PRODUCT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
328936	ASSURE PLATINUM BLOOD GLUCOSE SYSTEM	BLOOD GLUCOSE TEST SYSTEM	NBW	ARKRAY, INC.	500001	04074C

Patients

Seq	Age	Sex	Outcome	Treatment
1