MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4244269

Device Problem Calibration Error (1078)

Patient Problems Headache (1880); Dizziness (2194); Shaking/Tremors (2515)

Event Date 06/24/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging a calcode issue with his onetouch ultra2 meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient alleged that the calcode issue began around 4:10pm on (b)(6) 2018.The patient manages his diabetes with insulin (no adjustments).He denied making any changes to his usual diabetes management routine following the start of the alleged issue.He reported that 5 minutes later, he developed symptoms of ¿shaky, dizzy and headache¿.He denied receiving any treatment for his symptoms above or beyond the usual routine of diabetes care and management.During troubleshooting, the cca discovered that the patient¿s meter had been coded incorrectly to 27 instead of 25.The cca walked the patient through recoding the meter and the issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, i.E.Shaky, dizzy and headache, after having difficulty obtaining a blood glucose result on the meter because it had been coded incorrectly.

• Brand Name: OT ULTRA2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7653713
• MDR Text Key: 112841298
• Report Number: 3008382007-2018-01851
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4244269
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/24/2018
• Device Age: 41 MO
• Date Manufacturer Received: 06/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 72 YR
• Patient Weight: 91