MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT SELECT SIMPLE METER; GLUCOSE MONITORING SYS/KIT

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Sweating (2444); Palpitations (2467); Confusion/ Disorientation (2553)

Event Date 12/20/2019

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch select simple meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on the customer service agent (csa) documentation.The patient reported that the alleged meter inaccuracy occurred between (b)(6) 2019 and (b)(6) 2019 whilst in (b)(6).The patient reported that around 4 hours after dinner on the evening of (b)(6) 2019, he obtained a blood glucose result of around ¿11.0 mmol/l¿ with the subject meter.In response to the elevated result, the patient claimed he took his usual dose of 750 mg metformin and an additional gliclazide tablet.The patient claimed that in the early hours of (b)(6) 2019, he had a ¿very vivid dream of his dog that seemed real¿ and woke up at 4:45 am ¿sweating, confused and heart beating hard.¿ in response to the symptoms, the patient claimed his wife gave him a spoon of sugar, grapes, orange juice and chocolate biscuits.The patient reported that he felt better after treatment.During troubleshooting, the csa confirmed that the unit of measure was set correctly on the subject meter.The patient informed the csa that he was using expired test strips when he obtained the alleged inaccurate results.Replacement product was sent to the patient.This complaint is being reported because patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after taking extra blood glucose lowering medication based on an alleged inaccurate high result obtained with the subject meter.

• Brand Name: OT SELECT SIMPLE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 9719652
• MDR Text Key: 180780311
• Report Number: 3008382007-2020-03869
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: GB
• PMA/PMN Number: K072543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention