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

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Loss of Vision (2139)

Event Type  Injury  

Event Description

On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter was testing in settings mode.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the meter issue began on november 29, 2017.He reported that he manages his diabetes with insulin (no adjustments), and made no changes to his normal diabetes management regimen in response to the alleged issue.The patient alleges that on an unknown date/time after the product issue began, he developed symptoms of ¿eyes got bad, bad eye sight¿.In response to the symptoms the patient stated that he attended his doctor¿s office and was treated with ¿levemir insulin 50 units¿.During troubleshooting the csr noted this was not the first time the product was being used.The csr walked through a retest with the patient and the issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms and received treatment for a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter 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: 7107370
• MDR Text Key: 94474380
• Report Number: 3008382007-2017-23545
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• 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: Other Caregivers
• Type of Report: Initial
• Report Date: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• 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: 12/08/2017
• Device Age: 7 MO
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 12/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/03/2017
• 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; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 109