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 Problems Dizziness (2194); Presyncope (4410)

Event Date 03/31/2022

Event Type  Injury  

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 device (hospital meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6), 2022 shortly before 12:00 pm.The patient reported obtaining a blood glucose reading of ¿200 mg/dl¿ with the subject meter then ¿80 mg/dl¿ on the hospital meter, performed more than 30 minutes apart.The patient in on insulin pump therapy.The patient claimed that shortly before 12:00 pm on (b)(6), 2022, they administered an increased dose of insulin based on the ¿200 mg/dl¿ reading obtained with the subject meter and shortly after 12:00 pm felt ¿dizzy¿ and became ¿almost unconscious¿.The patient claimed they were treated with food by a family member at the onset of their symptoms and felt better by 12:45 pm.The patient indicated they were taken to the hospital and on arrival, at approximately 1:00 pm, their blood glucose measured ¿80 mg/dl¿ on the hospital meter.No additional treatment was reported.At the time of troubleshooting, the cca confirmed that an approved sample site was used for testing the cca noted 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 extra insulin based on an alleged inaccurate high result obtained with the subject meter.

Event Description

On april 01, 2022, the lay-user/patient contacted lifescan (lfs) united states, alleging that their onetouch ultra2 meter read inaccurately high compared to another device (hospital meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on march 31, 2022 shortly before 12:00 pm.The patient reported obtaining a blood glucose reading of ¿200 mg/dl¿ with the subject meter then ¿80 mg/dl¿ on the hospital meter, performed more than 30 minutes apart.The patient in on insulin pump therapy.The patient claimed that shortly before 12:00 pm on march 31, 2022, they administered an increased dose of insulin based on the ¿200 mg/dl¿ reading obtained with the subject meter and shortly after 12:00 pm felt ¿dizzy¿ and became ¿almost unconscious¿.The patient claimed they were treated with food by a family member at the onset of their symptoms and felt better by 12:45 pm.The patient indicated they were taken to the hospital and on arrival, at approximately 1:00 pm, their blood glucose measured ¿80 mg/dl¿ on the hospital meter.No additional treatment was reported.At the time of troubleshooting, the cca confirmed that an approved sample site was used for testing.The cca noted that the test strips were being stored incorrectly, outside the vial.The cca educated the patient on the correct storage of the strips.The cca noted 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 extra insulin based on an alleged inaccurate high 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 parkway; malvern PA 19355
• MDR Report Key: 14061142
• MDR Text Key: 290707960
• Report Number: 2939301-2022-03027
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/22/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/01/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/08/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Male