MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH ONE TOUCH ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4484883

Device Problem Imprecision (1307)

Patient Problems Fatigue (1849); Polydipsia (2604)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging a calcode issue with her onetouch ultra2 meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient contacted lfs concerned that from 8am on (b)(6) 2019, the meter was showing calcode 35 rather than calcode 25.The patient manages her diabetes with humalog insulin (sliding scale) and a once weekly dose of trulicity.She denied making any changes to her usual diabetes management routine after noticing code 35.She reported that an unspecified time later, she became "tired and thirsty".She denied receiving any treatment for her symptoms above or beyond the usual routine of diabetes care and management.During troubleshooting, the cca confirmed that the patient's meter had been coded incorrectly.The cca walked the patient through recoding the meter and the issue was successfully resolved.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, i.E.Tired and thirsty, after experiencing difficulties obtaining blood glucose results on her meter because it had been coded incorrectly.

• Brand Name: ONE TOUCH ULTRA2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 8770671
• MDR Text Key: 150373638
• Report Number: 2939301-2019-02380
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4484883
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/09/2019
• Distributor Facility Aware Date: 07/04/2019
• Event Location: Home
• Date Report to Manufacturer: 07/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening