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

Lot Number 5629084

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Fall (1848); Hypoglycemia (1912); Dysphasia (2195); Confusion/ Disorientation (2553); Dry Mouth (4485)

Event Date 03/20/2024

Event Type  Injury  

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.In addition, 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) 2024, the lay user/patient¿s daughter contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to another meter (livongo).The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the reporter and on further information obtained by the medical surveillance specialist (mss) after reviewing the call recording.The reporter stated that the alleged meter inaccuracy occurred on (b)(6) 2024, at 7:42 pm.The reporter claimed the patient obtained blood glucose readings of ¿409 mg/dl¿ with the subject meter and ¿129 mg/dl¿ on the other device, performed 3 minutes apart.The reporter claimed the patient¿s normal blood glucose range for that time of day is around ¿70-100 mg/dl¿.The patient manages her diabetes with a fixed dose of novolin 70/30 insulin (15 units morning and night, 30 minutes before meals).During the follow-up call, the reporter confirmed that as a result of the alleged issue, the patient took her usual dose of 15 units of insulin and ate her evening meal as normal.The reporter also informed the cca that when the patient receives a high reading, she usually gives her peanut butter and a lot of water but could not recall if that night she gave the patient that specifically.The reporter claimed that the following morning at 3:45 am, she discovered the patient had fallen out of bed and found her ¿lying on the floor very still, with no control of her mouth which was also dry, she did not have her full cognitive abilities, she was half conscious, she was out of it and incoherent¿.The reporter claimed she gave the patient a bottle of water with sugar, sugar tablets broken into quarters and a small can of pepsi.After treatment, the reporter claimed she checked the patient¿s blood glucose levels with the other meter constantly, receiving results of ¿20 mg/dl at 4:03 am and ¿40 mg/dl¿ at 4:29 am, until she fully recovered.During the follow-up call, the reporter attributed the event to the patient taking her normal dose of insulin after receiving the high result, and to giving the patient ¿stuff¿ to bring down the result.At the time of troubleshooting, the cca walked the reporter through a control solution test and the result fell outside the specified control solution range printed on the test strip vial.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly required the assistance of a third party for the treatment of an acute low blood glucose excursion after obtaining an alleged inaccurate high result with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• 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: 19068474
• MDR Text Key: 339684583
• Report Number: 3009698388-2024-00015
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5629084
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/20/2024
• 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