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

Model Number 021-924

Device Problem Device Handling Problem (3265)

Patient Problems Nausea (1970); Dizziness (2194); Syncope/Fainting (4411)

Event Date 02/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, the patient/lay user contacted lifescan (lfs) brazil by email alleging that his onetouch ultra mini meter read inaccurately low compared to a laboratory test.The complaint was classified based on the patient¿s email and on information obtained from the customer care agent (cca) during a follow up call with the patient.The patient reported that the alleged issue began on (b)(6) 2023, at 07:00 am.The patient claimed obtaining a blood glucose reading of ¿108 mg/dl¿ with the subject meter.The patient manages his diabetes with diet and exercise and claimed that at an unspecified time after he received the reading on the subject meter, he started feeling ¿dizziness and nausea¿ and went to the hospital.The patient reported that he ¿fainted¿ at the hospital.That same day at 09:00 am, the doctor performed a laboratory test and obtained a reading of ¿405 mg/dl¿.The patient stated that after the laboratory test, he was treated with an unspecified serum at the hospital.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood sample.The cca educated the patient on the use of control solution.The patient was unable to provide test strip details because he discarded the vial and test strips.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event and received hcp treatment for an acute high blood glucose excursion after using the product and the subject meter could not be ruled out as a cause or contributor to the 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.

• Brand Name: OT ULTRA MINI 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: 16526842
• MDR Text Key: 311125170
• Report Number: 3009698388-2023-00002
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/10/2023

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 Model Number: 021-924
• Device Catalogue Number: 021-924
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/10/2023
• 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; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male