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

Lot Number 4495437

Device Problem Material Opacification (1426)

Patient Problems Anxiety (2328); Distress (2329); No Code Available (3191)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/ patient contacted lifescan (lfs) (b)(4) alleging that his onetouch ultra2 meter had a cloudy display.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged product issue first started ¿6 months ago¿ when the subject meter¿s display screen became ¿cloudy¿.The patient alleged that this meant the subject meter¿s display was ¿hard to read¿.The patient manages his diabetes with insulin ¿ self adjuster and reported that ¿1 month and a half¿ after the start of the alleged product issue he took ¿less food and drink¿ in response to the alleged product issue.The patient reported that at an unspecified time after the start of the alleged product issue he began to develop the symptoms of ¿stress, anxiety and concern¿.The patient also reported that he ¿lost vision in right eye¿ however the csr verified that this symptom was attributed to another health condition unrelated to his diabetes.The patient reported that ¿1 month ago¿ he attended the emergency room (er) and received healthcare professional (hcp) treatment in the form of ¿42 units of insulin, lantus glargina¿.During troubleshooting, the csr verified that this was not the first time the patient had used the subject meter and based on the information provided there was no product misuse associated with the complaint.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment for an acute blood glucose excursion after the display of his onetouch ultra2 meter went ¿cloudy¿ which made it ¿hard to read¿.

• 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: 8706756
• MDR Text Key: 148260119
• Report Number: 3008382007-2019-02208
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4495437
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2019
• Device Age: 141 MO
• Date Manufacturer Received: 06/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2007
• 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