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

Lot Number	3958922
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Weakness (2145)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra2 meter read inaccurately high in comparison with her feelings or normal results.The complaint was classified based on customer care advocate (cca) documentation.The patient could not specify when the issue began however stated that she had obtained results of ¿250 and 330mg/dl¿ on the subject meter, which the patient felt was inaccurately high.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine the possibility of inaccuracy.The patient manages her diabetes by self-adjusting her insulin doses and administered her usual dose of insulin, increasing by 2 units every three days.The patient reported that ¿over time¿ after the alleged issue occurred she developed symptoms of ¿tired and weak¿ however denied receiving any treatment.During the call, it was determined that the meter was set to the correct unit of measure and the strips had not expired however had been stored incorrectly.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.

• 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: 6610200
• Report Number: 3008382007-2017-21435
• Device Sequence Number: 712554
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: (01)00353885000277
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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): 06/01/2017

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: 3958922
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/01/2017
• Device Age: 35 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2017
• Initial Report FDA Received Date: 06/03/2017
• 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