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

Lot Number 5677900

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 01/29/2024

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended including the reported meter.It was concluded that the number of complaints for the meter did not breach thresholds indicative of a systemic issue.In addition, similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.Investigation concluded that the device performed as intended by displaying an error message, protecting the user from an erroneous result.

Event Description

On january 30, 2024, a reporter for the lay user/patient contacted lifescan (lfs) india, alleging that the patient¿s onetouch select simple meter was displaying an ¿error 5¿ message during testing.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that on (b)(6) 2024, at around 8:00 am, the patient took their regular dose of 10 units of insulin (the patient normally manages their diabetes with 10 units of unspecified insulin twice a day, half an hour before breakfast and half an hour before going to bed).After some time, that same morning, the patient reportedly started to develop symptom of feeling ¿uneasy¿.In response to the symptom, the reporter claimed the patient attempted to test their blood glucose with the subject meter but received an error 5 message.As a result of the alleged issue, the patient reportedly thought that their blood glucose levels were high so took an additional dose of 10 units of insulin.Later that morning, the reporter claimed they found the patient ¿unconscious¿.The patient was taken to the hospital where they received a blood glucose result of ¿77 mg/dl¿ with the hospital meter.The patient was given glucose syrup and after 10 minutes the patient's blood glucose was re-tested with the hospital meter and the result was ¿85 mg/dl¿.The patient was given additional glucose syrup and after 20 minutes a further blood glucose test was performed with the hospital meter and the result was ¿105 mg/dl¿.The reporter claimed that after some time, the patient felt better and was discharged.At the time of troubleshooting, the cca noted the subject meter was not being used for the first time.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 the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• 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
• 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: 18665010
• MDR Text Key: 334833693
• Report Number: 3009698388-2024-00009
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K072543
• 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: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 5677900
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/30/2024
• 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; Hospitalization; Life Threatening
• Patient Age: 29 YR
• Patient Sex: Female