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

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Malaise (2359)

Event Date 11/10/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay user/patient¿s mother contacted lifescan (lfs) india, alleging that the patient¿s onetouch select simple 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 reporter stated that the alleged meter inaccuracy began about 20 days prior to contacting lfs when the patient obtained blood glucose results of ¿more than 400 mg/dl¿ with the subject meter.The patient manages their diabetes with a combination of oral medication (exact medication not communicated).The reporter informed the cca that when the alleged issue began, the patient tested their blood glucose in response to symptom of feeling ¿uneasy¿ and obtained readings of ¿450 and 435 mg/dl¿ with the subject meter.As a result of the elevated readings, the reporter claimed the patient took an increased dose of medication (1 extra tablet).Due to the symptoms observed and elevated readings obtained, the patient was taken to hospital where they received result of ¿50 mg/dl¿ on the hospital meter.The reporter claimed the patient was admitted to the hospital for "low sugar levels".The reporter was unwilling to provide details of the type of treatment given at the hospital.The patient was later discharged.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject.The cca noted that the test strips associated with the complaint had been discarded in the hospital.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after taking an increased dose of oral medication for diabetes (exact medication not communicated) based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT SELECT SIMPLE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 15936975
• MDR Text Key: 305043335
• Report Number: 2939301-2022-03127
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/07/2022

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/30/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female