FDA Adverse Event Injury Summary report: N

OT ULTRA EASY METER

MDR report key: 3811557 · Received May 15, 2014

Report

Report Number: 2939301-2014-11471
Event Type: Injury
Date Received: May 15, 2014
Date of Event: May 13, 2014
Report Date: May 14, 2014
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
PMA / PMN Number: K061118
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IT
Reporter Occupation: PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2014, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) ITALY ALLEGING HIS ONETOUCH ULTRAEASY METER READ INACCURATELY HIGH COMPARED TO HIS FEELINGS/ NORMAL BLOOD GLUCOSE RESULTS. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2014, AT 7PM, THE PATIENT REPORTED A BLOOD GLUCOSE RESULTS OF ¿108 MG/DL¿ WITH THE SUBJECT METER. THE PATIENT MANAGES HIS DIABETES WITH INSULIN (TYPE/ AMOUNT NOT SPECIFIED). THE PATIENT DID NOT TAKE ANY ACTION BASED ON THE ALLEGED RESULT. ABOUT 30 MINUTES AFTER THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT LOW BLOOD GLUCOSE SYMPTOMS OF SWEATING, BLURRED VISION AND TIREDNESS. THE PATIENT TOOK FOOD AND/ OR DRANK A BEVERAGE AS TREATMENT. THE PATIENT DENIED TESTING WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE SUBJECT METER WAS SET TO THE CORRECT UNIT OF MEASUREMENT. THE PATIENT DID NOT HAVE CONTROL SOLUTION TO PERFORM QUALITY CONTROL TESTING. THIS COMPLAINT IS BEING REPORTED BECAUSE THE PATIENT REPORTEDLY DEVELOPED SYMPTOMS SUGGESTIVE OF A SERIOUS INJURY AFTER THE ALLEGED METER ISSUE BEGAN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
289952	OT ULTRA EASY METER	GLUCOSE MONITORING SYS/KIT	NBW	LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL		3558897

Patients

Seq	Age	Sex	Outcome	Treatment
1	68 YR		Life Threatening\| R