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 Fatigue (1849); Hypoglycemia (1912); Loss of Range of Motion (2032); Vertigo (2134)

Event Date 07/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the reporter of the lay user/patient contacted lifescan (lfs) india, alleging that the patient¿s onetouch select simple meter was reading inaccurately high compared to their feelings and/or normal readings.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after a follow-up call with the patient.The reporter claimed that the alleged issue began three weeks prior to the call with lfs at an unspecified time.The reporter informed that the patient obtained a blood glucose reading of ¿500 mg/dl¿ with the subject meter.The patient usually manages his diabetes with human mixtard insulin (30 units in the morning and 50 units in the night) as prescribed by the doctor and the reporter stated that the patient continued taking his usual dose of medication in response to the high reading.At an unspecified time and date after the alleged issue occurred, the patient developed ¿hypoglycemic symptoms¿.During a follow-up call the patient explained that he is bed ridden and on the day of the event he felt ¿giddy, weak and less physical movement were observed¿.The patient also claimed that in response, the doctor was consulted by phone, who advised that the patient should be given sugar and water.The patient also indicated that the usual insulin doses were not given that day.During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca noted that the patient did not have control solution to test the subject system.The reporter did not provide details about testing technique and strip storage.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking their usual dose of insulin based on the alleged inaccurate high reading 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 pkwy; malvern PA 19355
• MDR Report Key: 15263291
• MDR Text Key: 298284358
• Report Number: 2939301-2022-03085
• 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: 08/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2022
• 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: 08/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 89 YR
• Patient Sex: Male