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

Lot Number 4392866

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

Patient Problems Visual Impairment (2138); Dizziness (2194); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

On february 5, 2019, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch select meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter inaccuracy began approximately one month prior to contacting lfs.The patient reported obtaining alleged inaccurate high blood glucose readings between ¿10.6-12.0 mmol/l¿ with the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient informed the csr that she manages her diabetes with ¿2 units¿ of glimepiride in combination with diet and exercise.The patient reported that an unspecified time before the alleged inaccuracy began she had developed symptoms of ¿dizziness, feeling of falling and visual impairment¿.The patient reported that in response to the alleged inaccurate high readings obtained with the subject meter she increased her dose of medication from "2 units to 3 or 4 units" of glimepiride.The patient reported that an unspecified time after taking the increased dose of glimepiride she felt ¿worse¿ and performed another test with the subject meter and a result of ¿3.1 mmol/l¿ was obtained.The patient self-treated her symptoms with sweets and reported feeling better.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure.In addition, the csr confirmed that the patient¿s test strips had been stored correctly and were within their expiry/discard date.The patient did not have control solution to perform a quality control test.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 after taking an increased dose of glimepiride in response to alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT SELECT METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8334341
• MDR Text Key: 135997404
• Report Number: 3008382007-2019-00419
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• PMA/PMN Number: K072543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 02/05/2019

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4392866
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/05/2019
• Initial Date Manufacturer Received: 02/05/2019
• Initial Date FDA Received: 02/13/2019
• 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