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 Dizziness (2194); Numbness (2415); Diaphoresis (2452); Shaking/Tremors (2515)

Event Date 12/16/2021

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 reporter of the lay user/patient contacted lifescan (lfs) usa alleging that his wife¿s onetouch ultra 2 meter displayed inaccurately high results compared to a laboratory device.The complaint was classified based on the customer care agent (cca) documentation.The reporter alleged that the issue first started on (b)(6) 2021, at an unspecified time.The reporter¿s wife obtained blood glucose readings of ¿400 and 330 mg/dl¿ on the subject meter and compared this to a reading of ¿129 mg/dl¿ on a laboratory device, taken less than 30 minutes apart from each other.The reporter claimed that his wife did not take any food or medication between the readings.The patient manages her diabetes with humalog insulin (self-adjuster) and the reporter stated that she increased her dose of insulin to 80 units in response to the alleged issue.At an unspecified time after the issue occurred on the same day, the patient developed symptoms of ¿dizziness, shakiness, sweatiness and loss of some senses¿.The reporter denied that the patient received any medical treatment but claimed that his wife only tested to verify her blood glucose levels.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca noted that the patient did not have control solution at the time of the call to test the subject system.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.

• 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: 13172981
• MDR Text Key: 288590644
• Report Number: 3009698388-2022-00006
• 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: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2022
• 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: 4679636
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/24/2021
• 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