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

Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Date of Event	12/17/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the patient contacted lifescan (lfs) alleging that she had had a packaging issue ¿ delica lancing device was missing from her onetouch ultra 2starter kit.The complaint was classified based on the customer care advocate (cca) documentation.The patient stated that the alleged missing product issue occurred in the afternoon of (b)(6) 2017.The patient manages her diabetes with oral medication, diet and exercise and denied making any change to her usual diabetes management routine in response to the alleged product issue.The patient reported that on (b)(6) 2017, 3:10pm after the alleged issue began she developed the symptom of ¿felt shaky¿, the patient stated that she was unsure if she was experiencing a high or low blood glucose excursion.The patient denied receiving any treatment.At the time of troubleshooting.When cca educated the patient on the correct contents that come with the kit, he confirmed there was no missing product.The patient¿s products were replaced and requested back for evaluation.This complaint is being reported because of the delay in treatment which the patient experienced after being unable to test their blood glucose using the subject meter due to the alleged missing product.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: 7141476
• Report Number: 3008382007-2017-23715
• Device Sequence Number: 1275511
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: 00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 12/20/2017

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: 12/20/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2017
• Initial Report FDA Received Date: 12/22/2017
• 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
• Patient Age: 78 YR
• Patient Weight: 74