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

Lot Number	4328360
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	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 displayed inaccurately high results compared to a laboratory device.The complaint was classified based on customer service representative (csr) documentation.The patient stated they first became aware of the meter issue, around dinner time on (b)(6) 2018, reporting that they had obtained an alleged inaccurately high blood glucose result of ¿350 mg/dl¿ on the subject meter compared to ¿130 mg/dl on a laboratory device.The tests were performed greater than 30 minutes of each other.The csr noted that the patient was unable to confirm how they managed their diabetes, but stated that after the meter issue began, she developed symptoms of ¿shaky¿, in response to these symptoms, she drank some water and went to the hospital at 10pm.The patient stated that a blood test was taken, then she was sent home with no other treatment.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 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: 7669242
• Report Number: 3008382007-2018-01932
• Device Sequence Number: 2643679
• Product Code: NBW
• UDI-Device Identifier: 00353885008167
• UDI-Public: 00353885008167
• Combination Product (Y/N): Y
• Initial Reporter State: NV
• 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): 06/30/2018

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: 4328360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/30/2018
• Device Age: 32 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2018
• Initial Report FDA Received Date: 07/09/2018
• 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