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

Lot Number	4475372
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Headache (1880); Sweating (2444)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra mini meter was displaying an unknown error message.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged error message first appeared approximately three months prior to contacting lfs.She stated that she manages her diabetes with oral medication (metformin; 2000mg per day), diet and exercise, and explained that she did not take any action in response to the alleged product issue.The patient informed the csr that after the product issue started, she began to experience ¿sweating and a headache¿ but denied receiving any treatment in response to her symptoms.At the time of troubleshooting, the alleged product issue remained unresolved.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 after she was unable to obtain a blood glucose reading due to the product issue.

• Brand Name: OT ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8685874
• Report Number: 3008382007-2019-02054
• Device Sequence Number: 19587990
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/28/2019

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
• Operator of Device: Lay User/Patient
• Device Lot Number: 4475372
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2019
• Device Age: 44 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 60