TRUETRACK

MDR report key: 4844485 · Received June 11, 2015

Report

Report Number: 1052693-2015-00896
Event Type: Malfunction
Date Received: June 11, 2015
Date of Event: May 15, 2015
Report Date: December 16, 2015
Manufacturer: NIPRO DIAGNOSTICS, INC.
Product Code: NBW
PMA / PMN Number: K032657
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). PRODUCT NOT YET RETURNED FOR EVALUATION.

Additional Manufacturer Narrative · 1

(B)(4). MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION USER HAS HIGH GLUCOSE VALUE. INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND.

Description of Event or Problem · 1

CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI". NEAL STATES ON BEHALF OF THE CUSTOMER THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 200MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 12/27/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND 566 MG/DL, FASTING. REVIEWED METER MEMORY; NO ADVERSE EVENT REPORTED.

Description of Event or Problem · 1

CONSUMER COMPLAINT OF BLOOD RESULTS READING "HI." (B)(6) STATES ON BEHALF OF THE CUSTOMER THAT HE FEELS WELL AND REQUIRES NO MEDICAL ATTENTION. CUSTOMER'S EXPECTED BLOOD RESULTS ARE 200MG/DL FASTING. VERIFIED THE STRIPS EXPIRE 12/27/2016. CUSTOMER CONFIRMS THE STRIPS ARE STORED PROPERLY AND WERE FIRST OPENED ON (B)(6) 2015. CUSTOMER PERFORMED BACK TO BACK BLOOD TEST, HI AND 566 MG/DL, FASTING. REVIEWED METER MEMORY: (B)(6). NO ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
381026	TRUETRACK	BLOOD GLUCOSE SYSTEM	NBW	NIPRO DIAGNOSTICS, INC.	TRUETRACK	RR4467

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR