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 Dysphasia (2195); Diaphoresis (2452); Shaking/Tremors (2515); Presyncope (4410)

Event Date 05/16/2022

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 (b)(6) 2022, the reporter contacted lifescan (lfs) usa, alleging that her husband¿s onetouch ultra 2 meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after medical surveillance listened to the call recording.The reporter did not provide details on when the alleged issue started.The reporter claimed that her husband¿s meter was brand new and stated that at an unspecified time and date she needed to call the emergency medical services because her husband was ¿sweating, shaking heavily, could not speak and almost to reach a coma¿.After the emergency medical services (ems) arrived, her husband received a blood glucose reading of ¿175 mg/dl¿ on the subject meter compared to a reading of ¿under 50 mg/dl¿ on the ems meter.The reporter claimed that there was no time difference between the readings.The reporter did not provide details on how her husband manages his diabetes, nor if he made any changes in response to the alleged issue.The reporter did not specify what kind of treatment her husband received but informed the agent that the ems team stayed for an hour making sure her husband¿s blood sugar was stable again.The reporter also claimed that the following day they went to the doctor¿s office and compared a reading of ¿over 500 mg/dl¿ on the subject meter to a reading of ¿200 mg/dl¿ on the doctor¿s meter.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter and the patient had used an approved sample site to obtain the blood samples.The reporter did not confirm whether the patient was following the correct testing procedure.The cca noted that the patient did not have control solution at the time of the call to test the subject system.The cca established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.Replacement products were sent to the patient.Even though the patient developed symptoms prior to the product issue, this complaint is being reported because the patient reportedly received hcp treatment for an acute low blood glucose excursion while using the product and there is insufficient information to rule out the contribution of the subject meter to the event and possible delay in treatment.

• 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: 14683342
• MDR Text Key: 293917913
• Report Number: 3009698388-2022-00024
• 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: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• 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: 4791644
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• 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): Required Intervention; Life Threatening