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

Lot Number	4363093
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Codes	Fainting (1847); 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 ultra mini meter was displaying a message saying ¿hi¿.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the meter issue began at 5 pm on (b)(6) 2018, when she obtained a message on the subject meter, that said ¿hi¿.The patient reported that she was unaware what the message meant.The patient reported that she manages her diabetes with a combination of medication (metformin and insulin), and that she made no changes to her normal diabetes management.The patient stated that she left the house to buy a new meter, and then developed symptoms of ¿shaky, blacked out and woke up in hospital¿.The patient was unable to confirm what treatment she received in hospital.During troubleshooting the csr noted that it was not the first time the patient was using the meter.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 the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter 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: 7676649
• Report Number: 3008382007-2018-01970
• Device Sequence Number: 16355836
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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): 07/05/2018

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: 4363093
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/05/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2018
• Initial Report FDA Received Date: 07/11/2018
• 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