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

Model Number 021-105

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Dizziness (2194); Shaking/Tremors (2515)

Event Date 05/17/2022

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 may 17, 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter read inaccurately erratic and inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on the morning of (b)(6) 2022.The patient claimed obtaining blood glucose readings of ¿95, 172 then 51 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The patient manages their diabetes with humalog insulin according to a sliding scale provided by their doctor.In response to the ¿172 mg/dl¿ reading which the patient felt was a little high, they administered a corresponding dose of humalog insulin and 5 hours after developed symptoms of feeling ¿shaky and dizziness¿.The patient claimed they tested their blood glucose with the subject meter 5 minutes after the onset of symptoms and a result of ¿51mg/dl¿ was obtained.The patient claimed they ate food to stabilize their blood glucose.During troubleshooting, the cca noted that the same approved sample site was used for testing and that the correct testing process was being followed.The cca confirmed the test strip vial was intact and that the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering insulin based on an alleged inaccurate result 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: 14545181
• MDR Text Key: 293266965
• Report Number: 3009698388-2022-00020
• 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: 05/30/2022

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: 4786968
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2022
• Initial Date FDA Received: 05/30/2022
• 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
• Patient Sex: Male