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

Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Fatigue (1849); Lethargy (2560)
Date of Event	01/07/2019
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 ultramini meter would not power on.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged meter power issue began on (b)(6) 2019 at 6 am.The patient informed the csr that she manages her diabetes with 1000 mg of metformin in the morning and evening as well as a combination of insulin shots; 3 short-acting and 1 long-acting daily (types and doses unspecified).The patient reported that in response to the alleged power issue with the subject meter she just continued with her usual diabetes management routine.The patient claimed that 3 days after the alleged power issue began she developed symptoms of feeling ¿fatigued and sleepy all day¿.The patient denied receiving any treatment or medical intervention.At the time of troubleshooting, the csr confirmed that the subject meter was not being used for the first time and based on the information provided there appeared to be no misuse to the product.Through troubleshooting the csr determined that the meter¿s battery needed replaced.However, the patient did not have any batteries to replace the meter with.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 she was unable to test her blood glucose with the subject meter due to the alleged power 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: 8364820
• Report Number: 3008382007-2019-00523
• Device Sequence Number: 19364670
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 02/18/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/18/2019
• Device Age: 53 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2019
• Initial Report FDA Received Date: 02/24/2019
• 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