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

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

Patient Problem Fainting (1847)

Event Date 07/28/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, a reporter for the lay user/patient contacted lifescan (lfs) usa, alleging that the patient's onetouch ultra mini meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording.The reporter was unable to recall when the alleged meter inaccuracy began.The reporter claimed that at an unspecified time on (b)(6) 2020, the patient obtained an inaccurate high blood glucose reading of "227 mg/dl" with the subject meter.The patient manages her diabetes with lantus insulin (10 units daily).The reporter denied the patient made any changes to her usual diabetes management regimen as a result of the alleged issue.During the call, the reporter claimed that at an unspecified time on (b)(6) 2020, after the alleged issue began, the patient "passed out." the reporter claimed she treated the patient with sugar water and the patient regained strength after.No other device was used for testing.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the patient was not washing hands prior to testing.Advice was given on the correct testing process.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness, IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness, IV2 3-ED ; UK IV2 3ED
• MDR Report Key: 10435666
• MDR Text Key: 203913647
• Report Number: 3008382007-2020-03977
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• 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
• Date Manufacturer Received: 07/29/2020
• 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