MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

Device Problem Device Alarm System (1012)

Patient Problems Syncope (1610); Dysphasia (2195); Sweating (2444)

Event Date 07/06/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter displayed an inaccurate "high glucose" message during testing; this warning appears when the meter detects blood glucose greater than 600 mg/dl.The complaint was classified based on the customer care agent (cca) documentation and on further information obtained when medical surveillance reviewed the call recording since the patient was unable to be reached by phone to obtain additional information.The patient stated that the alleged meter issue occurred on (b)(6) 2020 at around 6:00 pm.The patient is on intensive insulin therapy.In response to the meter message, the patient claimed she administered an increased dose of 130 units of insulin and within an hour her blood glucose dropped to "45 mg/dl" (device not reported) and she developed symptoms of "almost passed out, difficulty in coordinating speech, sweating and black spot on side of eye." the patient claimed that on (b)(6) 2020 at around 7:00 pm she was rushed to hospital.The treatment received was not reported however the patient claimed she was admitted to hospital for 4 days to regulate her blood glucose.At the time of troubleshooting, the cca noted that the subject meter was not being used for the first time and there was no indication of misuse of the device.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 taking an increased dose of insulin based on alleged inaccurate high message obtained with the subject meter.

• Brand Name: OT ULTRA 2 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: 10343896
• MDR Text Key: 201005525
• Report Number: 3008382007-2020-03970
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• 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: 07/15/2020

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 Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4626605
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/15/2020
• Initial Date FDA Received: 07/30/2020
• 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): Hospitalization; Life Threatening; Required Intervention