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

Model Number 021-105

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

Patient Problems Emotional Changes (1831); Cognitive Changes (2551)

Event Date 11/08/2021

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, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra 2 meter was reading inaccurately high compared to his feelings/normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient alleged that the inaccuracy issue began on (b)(6) 2021, at an unspecified time.The patient claimed obtaining a blood glucose reading of ¿234 mg/dl¿ with the subject meter.The patient informed the agent that he manages his diabetes with humalog and lantus insulin (self-adjuster) and stated that he used more insulin in response to the alleged issue.He specified that he increased his humalog insulin dose from 3 units to 12 units between november 8, 2021, and november 17, 2021.During this timeframe the patient developed symptoms of ¿feeling down, feeling like not enough oxygen was going to the brain and had problems thinking¿.The patient claimed that when his blood sugar goes low, he has problems thinking.The patient indicated that because he noticed the results he was getting were not accurate he decided to compare his results with another meter on (b)(6) 2021 at 10 a.M.He obtained a blood glucose reading of ¿224 mg/dl¿ with the subject meter compared to a reading of ¿181 mg/dl¿ on a ¿relion¿ meter.The patient denied receiving any medical treatment for the reported symptoms.At the time of troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject device at the time of testing.The cca noted that the patient did not have control solution available at the time of the call to test the subject device.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 insulin based on alleged inaccurate high results 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 INC.; 20 valley stream pkwy; malvern PA 19355
• 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: 13006450
• MDR Text Key: 287835502
• Report Number: 3009698388-2021-00002
• 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,Followup
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• 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: 4754589
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2022
• Date Manufacturer Received: 02/17/2022
• 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): Life Threatening
• Patient Age: 66 YR