MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	3934093
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Dizziness (2194); Shaking/Tremors (2515); Lethargy (2560)
Date of Event	06/01/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017 the lay user/patient contacted lifescan (lfs) alleging that his onetouch ultra2 meter was reading inaccurately high compared to another meter.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged inaccuracy issue began around mid-(b)(6) 2017 when blood glucose results of ¿350, 290 and 323mg/dl¿ were obtained using the subject device compared to a result of ¿158mg/dl¿ using an emergency services meter (brand unknown).The measurements were taken more than 30 minutes apart therefore invalidating the inaccuracy comparison.The patient manages his diabetes using pills, diet and/or exercise and reportedly increased his dose of glipizide from 5mg to 10mg in response to the alleged issue.The patient claimed experiencing symptoms of ¿light-headed, dizzy, very sleepy and shaky¿ although the patient was unable to specify if these symptoms began before or after the alleged issue, and reportedly received hcp treatment in the emergency room (er) of ¿ekg and heart-related treatment¿ on (b)(6) in response to the reported event.At the time of troubleshooting the csr confirmed that the meter was set to the correct unit of measure and confirmed an approved sample site was being used.The csr noted that the patient did not have any control solution, and also identified that the test strips being used (lot # 3934093) expired 06/2017.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 taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA2 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: 6796567
• Report Number: 3008382007-2017-22197
• Device Sequence Number: 13666726
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: (01)00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/11/2017

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: 3934093
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2017
• Device Age: 32 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2017
• Initial Report FDA Received Date: 08/16/2017
• 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
• Patient Age: 60 YR
• Patient Weight: 95