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

Lot Number 5653095

Device Problem Device Handling Problem (3265)

Patient Problem Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2023, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra2 meter was reading inaccurately erratic.This complaint was classified based on information obtained by the customer care agent (cca) during the initial call and additional information obtained when the cca followed-up with the patient.The patient was unable to recall when the alleged inaccuracy issue began; however, claimed obtaining blood glucose readings of ¿131 mg/dl¿ and ¿116 mg/dl¿ with the subject device on (b)(6) 2023, respectively, which they believed to be inaccurate.The patient manages their diabetes with insulin (type and dose not specified).The patient reported during the follow-up call with the cca that they administered an unspecified dose of insulin and that when they obtained the readings which they described as ¿high¿, they felt ¿shaky¿; however, it is not clear if the patient became symptomatic before or after administering insulin.The date the patient reportedly administered insulin is not known, nor is it known when they developed the symptom alleged.At the time of troubleshooting, the cca confirmed that an approved sample site was used to obtain the results and noted that the patient did not have control solution available to complete a quality control test with the subject system.This complaint is being reported because the patient reportedly developed symptoms which may be indicative of a serious injury adverse event for an acute low blood glucose excursion.The alleged inaccuracy issue could not be ruled out as a cause and/or contributor to the reported event.

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.Similar complaints for this issue were also 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.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern 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: 17458200
• MDR Text Key: 320382716
• Report Number: 3009698388-2023-00022
• 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: 08/04/2023

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 Lot Number: 5653095
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/04/2023
• 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