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

Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Diarrhea (1811); Renal Failure (2041); Urinary Frequency / Polyuria (2275)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, a reporter for the lay user/patient contacted lifescan (lfs) alleging that the patient¿s onetouch ultra2 meter kit was missing test strips and control solution.The complaint was classified based on customer care advocate (cca) documentation as the patient was not available when medical surveillance attempted to follow-up to obtain additional information relating to the complaint.The reporter could not specify when the issue was identified, but stated that the patient got the device on (b)(6) 2016.The patient manages her diabetes with fixed insulin doses and exercise.The reporter detailed that an unspecified time after the alleged issue occurred the patient developed symptoms of ¿frequent urination, diarrhea and kidney failure¿ and that on (b)(6) 2017 the patient was hospitalized where she had her blood glucose tested, but the reporter could not specify the results, and the patient was treated with iv fluids.During the call, it was determined that when the reporter was educated on the correct box contents there was no product missing.The product was replaced and requested back.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began.

• 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: 6597245
• Report Number: 3008382007-2017-21354
• Device Sequence Number: 18998422
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: (01)00353885000277
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 05/12/2017

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
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2017
• Device Age: 23 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2017
• Initial Report FDA Received Date: 05/30/2017
• 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: 85 YR
• Patient Weight: 77