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

Lot Number 4863068

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Appropriate Term/Code Not Available (3191)

Patient Problem Tachycardia (2095)

Event Date 09/03/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) mexico, alleging that their onetouch ultra meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first began on (b)(6) 2022, and that on the morning of (b)(6) 2022, they obtained an inaccurate high blood glucose reading of ¿153 mg/dl¿ with the subject meter.The patient manages their diabetes with oral medication (type not specified).The patient claimed they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported experiencing ¿tachycardia¿ on the morning of (b)(6) 2022, after obtaining the reading of ¿153 mg/dl¿ with the subject meter.The patient indicated they spoke with their doctor and the symptoms resolved after they self-treated with food.The patient denied their blood glucose was tested with any other device.The patient indicated they had their blood pressure measured during the time of the event and it was ¿ok¿.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

Event Description

On september 06, 2022, the lay-user/patient contacted lifescan (lfs) mexico, alleging that their onetouch ultra meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy first began on (b)(6) 2022, and that on the morning of (b)(6) 2022, they obtained an inaccurate high blood glucose reading of ¿153 mg/dl¿ with the subject meter.The patient manages their diabetes with oral medication (type not specified).The patient claimed they continued to follow their usual diabetes management regimen in response to the alleged issue.The patient reported experiencing ¿tachycardia¿ on the morning of (b)(6) 2022, after obtaining the reading of ¿153 mg/dl¿ with the subject meter.The patient indicated they spoke with their doctor and the symptoms resolved after they self-treated with food.The patient denied their blood glucose was tested with any other device.The patient indicated they had their blood pressure measured during the time of the event and it was ¿ok¿.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 15386254
• MDR Text Key: 299557551
• Report Number: 2939301-2022-03091
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4863068
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/06/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening