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

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problems Dysphasia (2195); Lethargy (2560)

Event Date 09/25/2021

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Event Description

On (b)(6) 2021, the reporter of the lay user/patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra 2 meter was reading inaccurate high compared to her feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after customer care (cc) reviewed the call again at medical surveillance request.The reporter claimed that the alleged issue began on (b)(6) 2021, at approximately 4 pm.The reporter advised that his wife obtained a blood glucose reading of ¿131 mg/dl¿ on the subject meter.The patient manages her diabetes with novolog insulin (self-adjuster) and the reporter stated that in response to the alleged issue, she administered 20 mg of novolog insulin.The reporter claimed that at the same time the patient started developing symptoms of ¿unintelligible speech¿ and ¿feeling sleepy¿.They called the emergency medical services (ems) and at 5:30 pm a blood glucose reading of ¿41 mg/dl¿ was obtained on an ems meter in the hospital.The patient was treated with intravenous therapy; however, the reporter did not recall whether it was with glucose or iv fluids.During troubleshooting, the cca was unable to confirm whether the unit of measure was set correctly on the subject meter.The cca established that the test strips had not expired but had been stored improperly or were open beyond their discard date.A replacement meter was 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 insulin based on alleged inaccurate high results 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 ; 1463383679
• MDR Report Key: 12662054
• MDR Text Key: 278626288
• Report Number: 3008382007-2021-04254
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• 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: 10/19/2021

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: 4651471
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/04/2021
• Initial Date FDA Received: 10/19/2021
• 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