FDA Adverse Event Malfunction Summary report: N

ACCU-CHEK ® AVIVA TEST STRIPS

MDR report key: 1832524 · Received September 13, 2010

Report

Report Number: 1823260-2010-05400
Event Type: Malfunction
Date Received: September 13, 2010
Date of Event: September 6, 2010
Report Date: November 22, 2010
Manufacturer: ROCHE DIAGNOSTICS
Product Code: LFR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

Narratives

Additional Manufacturer Narrative · 1

THE EVENT OCCURRED IN (B)(6). CUSTOMER DID NOT PROVIDE PRODUCT INFORMATION FOR THE COMPACT PLUS SYSTEM. COMPACT TEST STRIPS HAVE BEEN DISCARDED.

Description of Event or Problem · 1

I USED FIXODENT FOR ABOUT 10 YEARS. I HAVE NUMBNESS AND TINGLING IN MY ARMS AND LEGS. MY CONDITION IS PERMANENT. MY WRITING IS SHAKY. I AM ANEMIA, THE TASTE OF WATER IS BAD, I HAVE BACK TROUBLE, STANDING FOR ANY LENGTH OF TIME. I GET SICK TO MY STOMACH AND THROW UP. I GET LOOSE STOOLS, BAD TASTE, FEELS REAL BAD, SOMETIMES IT DON'T WORK A LOT OF TASTE BAD FEELING. CAN'T EAT VERY WELL CAUSE THE CREAM GETS LOOSE OR THE TASTE IS TOO BAD. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: 3X DAY, ROUTE: ORAL. DATES OF USE: (B)(6) 2000 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE CREAM ADHESIVE. EVENT ABATED AFTER USE STOPPED OR DOSE REDUCED: YES.

Description of Event or Problem · 1

CUSTOMER REPORTEDLY RECEIVED RESULTS OF 244 MG/DL AND 109 MG/DL ON THE AVIVA COMBO SYSTEM, AND 106 MG/DL ON THE COMPACT PLUS SYSTEM WITHIN 10 MINUTES. NO ACTIONS TAKEN BASED ON DEVICE RESULTS. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT DEVICE AND REPLACEMENT WAS SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACCU-CHEK ® AVIVA TEST STRIPS	BLOOD GLUCOSE MONITORING TEST STRIPS	LFR	ROCHE DIAGNOSTICS		202278

Patients

Seq	Age	Sex	Outcome	Treatment
1	034 YR			UNSPECIFIED INSULIN