OT VITA ENHANCED METER

Report

Report Number: 3008382007-2012-08746
Event Type: Injury
Date Received: December 20, 2012
Report Date: December 11, 2012
Manufacturer: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code: NBW
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

PRODUCT WAS REPLACED AND REQUESTED BACK FOR INVESTIGATION.

Description of Event or Problem · 1

THE REPORTER CONTACTED LFS (B)(4) ON (B)(6) 2012 AND LEFT A VOICE MESSAGE TO LFS ON NEEDING HELP ON SETTING UP THE METER. CUSTOMER SERVICE CONTACTED THE REPORT BACK AND HE MENTIONED THAT HIS WIFE HAD OBTAINED INACCURATE HIGH READINGS ON HER METER AND DUE TO THAT SHE HAD CHANGED HER DIABETES REGIMEN. THE PATIENT HAD BEEN COMPARING HER METER READINGS TO FEELINGS/ NORMAL RESULTS. AT AN UNSPECIFIED TIME LATER HIS WIFE DEVELOPED HYPOGLYCEMIC SYMPTOMS AND WAS TAKEN TO THE HOSPITAL. A MEDICAL SURVEILLANCE SPECIALIST (MSS) SENT FOLLOW UP QUESTIONS IN REGARDS TO THIS INCIDENT; HOWEVER, THE REPORTER REFUSED TO ANSWER ANY ADDITIONAL QUESTIONS. THE FOLLOWING WAS CLASSIFIED BASED ON THE INITIAL CALL. IT IS UNKNOWN WHAT THE CONDITION OR EXPIRATION DATE OF THE TEST STRIPS THE PATIENT HAD BEEN USING. NO FURTHER CLINICAL INFORMATION WAS PROVIDED. IT WOULD HAVE BEEN HELPFUL TO KNOW THE PATIENT'S DIABETES REGIMEN, READINGS PRIOR TO THE INCIDENT, HOW SOON AFTER THE PATIENT HAD DEVELOPED SYMPTOMS, INITIAL READING IN THE HOSPITAL, EXACT SYMPTOMS AND DIAGNOSIS. THE PRODUCT WAS REPLACED. THE COMPLAINT IS BEING REPORTED SINCE THE REPORTER ALLEGED THAT DUE TO THE METER PROVIDING INACCURATE HIGH RESULTS, THE PATIENT ADJUSTED THEIR INSULIN, LATER DEVELOPED SYMPTOMS AND HAD TO BE TAKEN TO THE HOSPITAL.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Life Threatening