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

Lot Number	U230418A12
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Hyperglycemia (1905); Vomiting (2144)
Date of Event	10/09/2024
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On october 17, 2024, the lay user/patient contacted lifescan (lfs) united states, alleging that her onetouch ultra2 meter read inaccurately erratic.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the patient.The patient reported that the alleged meter inaccuracy began probably 1 year prior to contacting lfs.The patient reported obtaining blood glucose readings of ¿500, 300, 200 and 335 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The patient manages her diabetes with a combination of insulin and oral medication.She reported taking more insulin in response to the alleged inaccurate readings.She reported that she began ¿throwing up¿ and could ¿not eat anything¿ at unspecified dates and times due to the alleged issue.During the follow-up call, the patient indicated that she associated the symptoms with a high blood glucose level.On (b)(6) 2024, the patient went to the hospital and was admitted to the intensive care unit.During the follow-up call, the patient stated that her blood glucose was measured on arrival at the hospital but was unable to recall the result obtained.No diagnosis was provided.The patient could not recall the type of treatment received but mentioned she was given a lot of medication.The patient was hospitalized for 2 days.During the follow-up call, the patient attributed the symptoms to the insulin she had to take.During troubleshooting, the cca confirmed 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 products were sent to the patient.This complaint is being reported because the patient reportedly required hospitalization after obtaining alleged inaccurate blood glucose readings with the subject meter and it is not known what treatment the patient received.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: 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: 20593773
• Report Number: 3009698388-2024-00034
• Device Sequence Number: 18335370
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2024

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
• Operator of Device: Lay User/Patient
• Device Lot Number: U230418A12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown