FDA Adverse Event Malfunction Summary report: N

RELION PRIME BLOOD GLUCOSE SYSTEM

MDR report key: 4210559 · Received October 29, 2014

Report

Report Number: 1832816-2014-00080
Event Type: Malfunction
Date Received: October 29, 2014
Date of Event: October 7, 2014
Report Date: October 29, 2014
Manufacturer: ARKRAY, INC.
Product Code: NBW
PMA / PMN Number: K091102
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE HISTORY RECORDS WERE REVIEWED AND NO ANOMALIES WERE DETECTED. PRODUCT INVOLVED IN INCIDENT WAS RETURNED AND EVALUATED. THE RETURNED PRODUCT PERFORMED WITHIN SPECIFICATION. NO FAILURE DETECTED.

Description of Event or Problem · 1

CALLER INDICATED THE RELION PRIME METER WAS GIVING HIGH READINGS. CALLER FEELS THAT SHE IS GETTING INACCURATE RESULTS AND JUST WANTS A REFUND FOR METER AND STRIPS. SHE JUST BOUGHT THE METER YESTERDAY AND WHEN SHE TESTED IT SHE RECEIVED A NUMBER THAT WAS ALMOST 600 SO SHE TOOK A READING ON HER OTHER METER AND IT WAS 180. HER DOCTOR IS GOING TO WRITE A SCRIPT FOR HER OTHER METERS STRIPS SO SHE IS REQUESTING A REFUND FOR THIS PRODUCT. 10/9/14 CONTACTED CUSTOMER AND VERIFIED THE READINGS WERE TAKEN WITHIN 10 MINUTES. VERIFIED PROPER TECHNIQUE AND STORAGE. CUSTOMER STORES HER SUPPLIES IN HER BEDROOM, CHANGES LANCETS EVERY TIME SHE TESTS, WASHES HANDS WITH SOAP AND WATER AND ALLOWS FINGERS TO DRY BEFORE LANCING. SHE IS UNSURE WHAT HER NORMAL GLUCOSE READINGS ARE. SHE IS NOT RECEIVING ANY OXYGEN THERAPY AND DOESN'T HAVE ISSUES GETTING BLOOD. SHE KNOWS WHEN HER SUGAR IS HIGH. SHE WOULD HAVE SYMPTOMS BUT SHE WAS FEELING PERFECTLY FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
691929	RELION PRIME BLOOD GLUCOSE SYSTEM	BLOOD GLUCOSE TEST SYSTEM	NBW	ARKRAY, INC.	701103	09044C

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR