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

Lot Number	4097310
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Vertigo (2134); Dizziness (2194); Malaise (2359)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter continued to display the apply sample icon instead of counting down and providing a blood glucose result.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter issue began 3 weeks prior to contacting lfs.The patient informed the csr that she manages her diabetes with ¿lecimitril 2.5¿ and claimed she took her usual dose of medication on (b)(6) 2018 at 4:00 pm in response to the alleged issue.The patient reported developing symptoms of ¿lightheadedness, felt ill, off balance, did not feel good¿ an unspecified time after the alleged issue began.The patient denied receiving any medical treatment.At the time of troubleshooting, the csr noted the subject meter was not being used for the first time.It was noted that the correct strips were being used for testing and that the correct testing process was being followed.The csr noted the patient did not have testing supplies available to test the meter.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged meter issue began.

• Brand Name: OT ULTRA2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7322870
• Report Number: 3008382007-2018-00749
• Device Sequence Number: 110241
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: 00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 02/28/2018

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: 4097310
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/28/2018
• Device Age: 8 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 03/08/2018
• 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