MAUDE Adverse Event Report: LIFESCAN INC. LEGACY METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4653955

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Blurred Vision (2137); Discomfort (2330); Arthralgia (2355)

Event Date 11/15/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2022, the patient/lay user contacted lifescan (lfs) mexico alleging that his onetouch ultra meter read inaccurately low compared to a laboratory device.The complaint was classified based on the customer care agent (cca) documentation.The patient alleged that the subject meter started displaying an inaccurate low reading on an unspecified date in (b)(6) 2021 at 6:30 am.The patient obtained a blood glucose reading of ¿125 mg/dl¿ on the subject meter compared to a reading of ¿240 mg/dl¿ on a laboratory device, obtained at 8:00 am that same morning.The patient manages his diabetes with a combination of diabetes medications (metformin with glibenclamide 30 mg in the morning) and stated that he continued taking his usual dose in response to the alleged issue.The patient also indicated that he thought the meter was giving him normal readings, therefore he felt overconfident and started eating more.At an unspecified time after the alleged issue occurred, the patient started to develop symptoms of ¿heavy legs, cloudy vision and pain in the joints and bones¿.The patient went to the doctor¿s office and the doctor prescribed pioglitazone 30 mg, modified his diet, and advised to get the meter changed.The patient informed that before treatment an unspecified blood glucose reading on an hcp meter was obtained.During troubleshooting, the cca established that the test strip vial was intact, that the test strips had been stored properly, and had not expired.The cca noted that the patient did not have control solution at the time of the call to test the subject system.A replacement meter was sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event and received hcp treatment after the alleged product issue began.

• Brand Name: LEGACY 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: 13866146
• MDR Text Key: 293149664
• Report Number: 3009698388-2022-00011
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: MX
• 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: 03/22/2022

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 Lot Number: 4653955
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2022
• Initial Date FDA Received: 03/23/2022
• 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): Required Intervention; Life Threatening