TRUERESULT

MDR report key: 4110729 · Received September 16, 2014

Report

Report Number: 1052693-2014-00329
Event Type: Malfunction
Date Received: September 16, 2014
Date of Event: August 20, 2014
Report Date: December 21, 2015
Manufacturer: NIPRO DIAGNOSTICS, INC.
Product Code: NBW
PMA / PMN Number: K080641
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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

Additional Manufacturer Narrative · 1

(B)(4). INVESTIGATION COMPLETED AND PRODUCT EVALUATED WITH NO DEFECTS FOUND. MOST LIKELY UNDERLYING ROOT CAUSE OF MALFUNCTION: USER HAD AN INACCURATE REFERENCE OR USER REUSED TEST STRIP OR USER'S TEST STRIP HAD POOR FILL. PRODUCT CODES UPDATED.

Description of Event or Problem · 1

CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 102 MG/DL FASTING AND 130-150 MG/DL TWO HOURS AFTER A MEAL. BACK TO BACK BLOOD TEST RESULTS WERE 81 AND 83 MG/DL. LAST 5 RESULTS IN MEMORY WERE 117 MG/DL, 61 MG/DL, 180 MG/DL, 86 MG/DL, AND 83 MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVE (61) AND THE NORMAL RESULT (102) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

Description of Event or Problem · 1

CONSUMER COMPLAINT OF LOW BLOOD RESULTS. CALLER NORMALLY IS AROUND 102MG/DL FASTING AND 130-150MG/DL TWO HOURS AFTER A MEAL. BACK TO BACK BLOOD TEST RESULTS WERE 81 AND 83MG/DL. LAST 5 RESULTS IN MEMORY WERE 117MG/DL, 61MG/DL, 180MG/DL, 86MG/DL, AND 83MG/DL. BASED ON PARKES ERROR GRID ANALYSIS, THE BIAS BETWEEN THE LOWEST RESULT GIVEN (61) AND THE NORMAL RESULT (102) IS LOCATED IN ZONE B/C. NO ADVERSE EVENT REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
571914	TRUERESULT	BLOOD GLUCOSE SYSTEM	NBW	NIPRO DIAGNOSTICS, INC.	TRUERESULT	PR1887

Patients

Seq	Age	Sex	Outcome	Treatment
1	0 YR