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

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Malaise (2359); Loss of consciousness (2418)

Event Date 11/17/2023

Event Type  Injury  

Event Description

On november 22, 2023, a reporter for the lay user/patient contacted lifescan (lfs), alleging that the patient¿s onetouch select simple meter read inaccurately high compared to his feelings and/or normal readings.The complaint was classified based on additional information obtained by the customer care agent (cca) during a follow-up call with the reporter.The reporter stated that the alleged meter inaccuracy began on (b)(6) 2023.The reporter claimed the patient obtained alleged inaccurate high readings of ¿450 mg/dl¿ fasting and ¿550 mg/dl¿ postprandial with the subject meter.The patient¿s normal blood glucose levels are around ¿100 mg/dl" fasting and around ¿150 mg/dl¿ postprandial.The patient usually takes glycigon-80mg half tablet before lunch and after dinner to manage his diabetes.As a result of the alleged issue, the reporter claimed the patient consulted his doctor and was advised to increase the dose of glycigon-80 mg to 1 tablet before lunch and after dinner.The patient continued with the increased dosage for 2 days.On (b)(6) 2023, the patient began feeling ¿uneasy¿ and fell ¿unconscious¿.During the follow-up call, the reporter confirmed the patient was given glucose syrup and then taken to the hospital.The reporter confirmed the patient¿s blood glucose was measured on arrival at hospital and the result was ¿170 mg/dl¿.The doctor reportedly informed that the patient¿s sugar levels had become very low.The reporter was unable to provide any details of the treatment provided in the hospital.The reporter attributed the onset of the patient¿s symptoms to the high readings obtained with the subject meter which they claimed mislead the treatment.At the time of the follow-up call, the patient was still in hospital.The patient was to be discharged on (b)(6) 2023.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the test strips had been opened past their discard date.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 after taking treatment based on alleged inaccurate high readings 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: 18216215
• MDR Text Key: 329120206
• Report Number: 2939301-2023-00093
• 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: 11/28/2023

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Female