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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dizziness (2194); Sweating (2444); Shaking/Tremors (2515)
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 ultramini meter read inaccurately high compared to another meter.The complaint was classified based on the customer service representative (csr) documentation.The patient was unable to specify when the alleged inaccuracy began but reported that it happened approximately 3 weeks ago.The patient reported that she obtained an inaccurate high reading of "142 mg/dl" compared to a result of "118 mg/dl" on an unknown device, the tests were performed within 30 minutes of each other.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 manages her diabetes with diet and exercise and reported that she continued with her usual diabetes management routine after the alleged inaccuracy issue began.The patient claimed that at an unspecified time she developed symptoms of "sweating, shaking and dizziness" which she associated with symptoms of low blood sugar.The patient reported that she went to her doctor in response to her symptoms but denied receiving any treatment or medical intervention as a result of the product issue.The patient reported that the doctor only monitored her blood glucose results.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure and the patient had used an approved sample site to obtain the blood samples.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 obtaining alleged inaccurate results with the subject meter.

• 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: 8068195
• Report Number: 3008382007-2018-03127
• Device Sequence Number: 19230798
• 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): 11/07/2018

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/07/2018
• Device Age: 102 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2018
• Initial Report FDA Received Date: 11/14/2018
• 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
• Patient Weight: 79