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

Lot Number	4509978
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient contacted lifescan (lfs) usa, alleging that his onetouch ultra mini meter was reading inaccurately high compared to another meter (emergency services meter).The complaint was classified based on customer service representative (csr) documentation.The patient stated the meter issue began at 4.45 pm on (b)(6) 2019, reporting that he obtained an alleged inaccurately high blood glucose result of "161 mg/dl" on the subject meter compared to "38 mg/dl" on the other device.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter's reading is erroneous as the comparison is not made to a calibrated reference method.The patient reported that he manages his diabetes with insulin and metformin and made no changes to his normal diabetes management regimen.The patient was unable to describe any symptoms he developed but stated at 5 pm on (b)(6) 2019 he was treated by paramedics with iv glucose.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter, and an approved sample site was used.The csr noted that the patient did not have control solution.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical treatment for a serious injury adverse event, while using the product, and the alleged meter issue could not be ruled out as a cause or contributor to the event.

• Brand Name: ONE TOUCH ULTRAMINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 8802069
• Report Number: 2939301-2019-02371
• Device Sequence Number: 327480
• Product Code: NBW
• UDI-Device Identifier: 00353885000512
• UDI-Public: 00353885000512
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019
• Report Date (Section F): 07/18/2019

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: 4509978
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/01/2019
• Event Location: Home
• Date Report to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2019
• 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
• Date Report Sent to FDA: 07/18/2019