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

Model Number 021-105

Device Problem Device Handling Problem (3265)

Patient Problem Shaking/Tremors (2515)

Event Date 09/18/2022

Event Type  Injury  

Manufacturer Narrative

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.In addition, 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) 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter read inaccurately high compared to another meter (clinic meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began 1 week prior to contacting lfs and that on (b)(6) 2022, they obtained blood glucose readings of ¿more than 400 mg/dl¿ with the subject meter compared to ¿83 mg/dl¿ on a clinic meter, performed within 30 minutes of each other.The patient stated that they manage their diabetes with insulin (unspecified type and dosage) and that on (b)(6) 2022, they started taking more insulin due to the alleged issue.The patient reported that on (b)(6) 2022, they began to ¿shake¿.In response to the symptom, the patient indicated they went to the urgent care clinic where their blood glucose measured ¿83 mg/dl¿ on the clinic meter.No additional treatment was specified.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and an approved sample site was used for testing.The cca noted the test strips associated with the complaint had expired.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event after taking more 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 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: 15459760
• MDR Text Key: 300313875
• Report Number: 3009698388-2022-00049
• 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: 09/20/2022

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: 4208874
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 09/20/2022
• 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