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 Fatigue (1849); Dizziness (2194); Diaphoresis (2452)

Event Date 11/20/2021

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.In addition, similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.

Event Description

On (b)(6) 2021, a reporter for the lay-user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to another meter (ambulance meter).The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that on (b)(6) 2021 at 8:55 am, the patient obtained an alleged inaccurate high blood glucose reading of ¿119 mg/dl¿ with the subject meter.The patient manages his diabetes with insulin (23 units in the morning and 13 units at night).The reporter claimed the patient administered his usual dose of 23 units of insulin in response to the elevated result and 35 minutes later developed symptoms of feeling ¿really weak, sweaty, dizzy and looked like he was having a stroke¿.Emergency medical services (ems) were contacted for assistance.When the ambulance arrived at 10:15 am, the reporter claimed the patient¿s blood glucose measured ¿29 mg/dl¿ on the ambulance meter and was then administered glucose 10% intravenous infusion.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted that an approved sample site was used for testing.The cca noted 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 received medical intervention for an acute low blood glucose excursion after administering insulin based on an alleged inaccurate high result obtained with the subject meter.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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: 12858335
• MDR Text Key: 281199194
• Report Number: 3008382007-2021-04275
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• 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,Followup
• Report Date: 02/02/2022

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: 4739952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2022
• Initial Date Manufacturer Received: 11/20/2021
• Initial Date FDA Received: 11/22/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention; Life Threatening