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

Lot Number 4200784

Device Problem Calibration Error (1078)

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

Event Date 09/04/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter was set to the incorrect calibration code number.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter issue began on (b)(6) 2017 at around 7:00 am.The patient stated that she manages her diabetes with oral medication, diet and exercise and denied making any changes to her usual diabetes management regimen in response to the alleged issue.The patient reported that on (b)(6) 2017, about 6 days after the alleged issue began, she developed symptoms of feeling ¿lightheaded, shaky and dizzy.¿ the patient denied receiving any treatment beyond the usual routine of diabetes care and management in response to the symptoms.During troubleshooting, the csr assisted the patient with changing the code number on the subject meter and the alleged issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 6847588
• MDR Text Key: 85084845
• Report Number: 3008382007-2017-22433
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• 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: Patient
• Type of Report: Initial
• Report Date: 09/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4200784
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/04/2017
• Device Age: 85 MO
• Date Manufacturer Received: 09/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2010
• 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