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

Lot Number 4475605

Device Problem Imprecision (1307)

Patient Problems Headache (1880); Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that she was having a calcode issue with her onetouch ultra meter.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the meter issue began at 10.30 pm on (b)(6) 2019.The patient confirmed that she manages her diabetes, with insulin (no-adjustments).There is no evidence she made any changes to her normal diabetic routine.The patient alleges that 8 hours after the issue began, she developed symptoms of ¿profuse sweating and headache¿, which she self-treated by eating an apple.Csr noted that the issue was resolved with a walk through test.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, and there is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT ULTRA 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: 8829786
• MDR Text Key: 152311180
• Report Number: 3008382007-2019-03054
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K062195
• 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: 07/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4475605
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Device Age: 75 MO
• Date Manufacturer Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2013
• 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