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

Lot Number	4394390
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Fainting (1847)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a reporter on behalf of the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultramini meter was displaying an error message.The complaint was classified based on customer service representation (csr) documentation and further information obtained when medical surveillance reviewed the initial call.The reporter claimed that about a month ago (date not specified) before contacting lfs the patient was unable to obtain results on her meter as it kept showing the message "error 5".The reporter informed the csr that the patient manages her diabetes with humulin 70/30 and that she continued with her usual diabetes management routine after the alleged issue began.The reported claimed that an unspecified time after the alleged issue started she ¿got sick¿ because she was unable to check her blood sugar and specified that she ¿felt funny", was ¿getting lightheaded¿ and ¿falling¿.The reporter claimed that in response to the patient falling they would help her sit down, treat her with food and drink and she would be ok after a couple of seconds.The reporter also claimed that when she was not there to help (dates not specified), the patient would call the paramedics who would measure her blood glucose using their meter.The results were reportedly either ¿too high¿ or ¿too low¿.No further details of any other form of medical treatment was reported.  at the time of troubleshooting, the csr noted the subject meter was not being used for the first time and based on the information provided the patient was following the correct testing procedure.The csr confirmed that the test strips were within expiry/discard date.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event after she was unable to test her blood glucose with the subject meter due to the alleged meter issue.

• Brand Name: OT ULTRAMINI 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: 7913375
• Report Number: 3008382007-2018-02654
• Device Sequence Number: 19168381
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 09/18/2018

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: 4394390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/18/2018
• Device Age: 37 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 09/27/2018
• 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; Required Intervention