FDA Adverse Event Malfunction Summary report: N

OT VERIO IQ METER

MDR report key: 3101012 · Received May 8, 2013

Report

Report Number
3008382007-2013-10736
Event Type
Malfunction
Date Received
May 8, 2013
Report Date
May 7, 2013
Manufacturer
LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL
Product Code
NBW
PMA / PMN Number
K110637
Removal / Correction Number
2013-IE-017
Product Problem
Yes
Report Source
Manufacturer report
Reporter Location
CA
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ON (B)(6) 2013, THE LAY USER/ PATIENT CONTACTED LIFESCAN (LFS) (B)(4) ALLEGING HIS ONETOUCH VERIO IQ METER DISPLAYED AN "ERROR 2" MESSAGE. THE COMPLAINT WAS CLASSIFIED BASED ON THE CUSTOMER CARE ADVOCATE (CCA) DOCUMENTATION. THE ALLEGED ISSUE BEGAN ON (B)(6) 2013, AT 6PM. THE PATIENT MANAGES HIS DIABETES WITH ORAL MEDICATIONS (TYPE/ AMOUNT NOT SPECIFIED). IT IS NOT KNOWN IF THE PATIENT MADE CHANGES TO HIS USUAL MANAGEMENT ROUTINE. PRIOR TO THE START OF THE ALLEGED ISSUE, THE PATIENT CLAIMED HE FELT SYMPTOMS OF "A LITTLE PEAKY," LIGHT HEADED AND ANXIOUS. THE PATIENT ATE FOOD AS TREATMENT AND WENT FOR A WALK TO HELP WITH HIS SYMPTOMS. THE PATIENT DENIED TESTING WITH ANOTHER DEVICE. AT THE TIME OF TROUBLESHOOTING, THE CCA NOTED THE CORRECT TEST STRIPS WERE BEING USED FOR TESTING AND THERE WAS NO INDICATION OF MISUSE. THE ALLEGED ISSUE WAS NOT RESOLVED WITH RETESTING. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THE REPORTED ISSUE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE PATIENT'S REPORTED SYMPTOMS OF "PEAKY, LIGHT HEADED AND ANXIOUS" DOES NOT MEET LIFESCAN'S CRITERIA FOR A SERIOUS INJURY. THE PATIENT ALSO DENIED RECEIVING TREATMENT AS A RESULT OF THE ALLEGED ISSUE. HOWEVER, THIS COMPLAINT IS BEING REPORTED BECAUSE THE ALLEGED "ERROR 2" MESSAGE REMAINED UNRESOLVED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
201766 OT VERIO IQ METER GLUCOSE MONITORING SYS/KIT NBW LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL 3414371

Patients

Seq Age Sex Outcome Treatment
1 58 YR