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

Device Problem Date/Time-Related Software Problem (2582)

Patient Problem Shaking/Tremors (2515)

Event Date 06/27/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a reporter for the patient (the patient¿s pharmacist) contacted lifescan (lfs) usa, alleging a date/time issue with the patient¿s onetouch ultramini meter.The complaint was classified based on the customer care advocate (cca) documentation.The reporter alleged that the meter was ¿not working properly¿ because she was having a hard time setting up the date and time.She alleged that the issue started between 6am and 9am on (b)(6) 2018.The patient manages her diabetes with oral medication of metformin.The reporter alleged that as a result of being unable to set up the date/time, the patient was unable to check her blood glucose level for 2 weeks; she denied that the patient made any changes to her usual diabetes management routine following the start of the alleged issue.She reported that between 5am and 7am on (b)(6) 2018, the patient developed ¿shakiness¿.She denied that the patient received any treatment for her symptom above or beyond the usual routine of diabetes care and management; she reported that the patient simply ¿rested and went on her daily routine¿.During troubleshooting, the cca noted that the meter was being used for the first time.The cca walked the reporter through resolving the issue and the issue was resolved.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event i.E.Shakiness, after being unable to set up the meter¿s date and time and reportedly being unable to check her blood glucose level for 2 weeks.

• Brand Name: OT ULTRAMINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7693097
• MDR Text Key: 114139638
• Report Number: 3008382007-2018-02016
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/11/2018
• Device Age: 6 MO
• Date Manufacturer Received: 07/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening