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

Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Codes	Syncope (1610); Fatigue (1849)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa alleging that their onetouch ultramini meter displayed an error 5 message.The complaint was classified based the customer care advocate (cca) documentation as the patient was unable to be contacted, despite numerous attempts, in order to obtain additional information.The patient did not state when the alleged product issue occurred.The patient manages their diabetes with x2 500mg metformin tablets per day and did not make any changes to their usual diabetes management regimen as a result of the alleged product issue.An unspecified time in relation to the alleged product issue the patient developed symptoms of ¿tired and ready to fall over and pass out¿; however, it was documented that the patient did not require any form of treatment as a result of these symptoms.At the time of troubleshooting the cca noted that the patient¿s testing technique was correct and this was not the first time the product had been used.The patient¿s products were replaced.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event while using the product.The alleged meter issue could not be ruled out as a cause or contributor to the event.

• 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: 7701628
• Report Number: 3008382007-2018-02026
• Device Sequence Number: 2580249
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: VA
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 07/09/2018

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: 07/09/2018
• Device Age: 26 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 07/19/2018
• 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