MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 3936290

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Visual Disturbances (2140)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her 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 around (b)(6) 2019.She reported that she manages her diabetes with oral medication metformin 500 mg, diet and exercise and made no changes to her normal diabetes management regimen in response to the alleged issue.The patient alleges on an unknown date/time after the product issue began, she developed symptoms of ¿blurry vision and tiredness¿.There is no evidence the patient required or received any treatment for the alleged symptoms, other than taking her normal medication.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 not resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that may be suggestive of 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 GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8859203
• MDR Text Key: 153210860
• Report Number: 3008382007-2019-03179
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3936290
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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