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

Model Number	021-924
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	Nausea (1970); Dizziness (2194); Syncope/Fainting (4411)
Date of Event	02/25/2023
Type of Reportable Event	Serious Injury
Event or Problem 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.
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.

• Brand Name: OT ULTRA MINI 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: 16526842
• Report Number: 3009698388-2023-00002
• Device Sequence Number: 17457778
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 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
• Operator of Device: Lay User/Patient
• Device Model Number: 021-924
• Device Catalogue Number: 021-924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 03/10/2023
• 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: Life Threatening; Hospitalization
• Patient Age: 45 YR
• Patient Sex: Male