MAUDE Adverse Event Report: LIFESCAN INC OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

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

Patient Problems Fatigue (1849); Dizziness (2194); Anxiety (2328); Shaking/Tremors (2515); Alteration in Body Temperature (4568)

Event Date 05/12/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 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 began on (b)(6) 2022.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿267, 325, 355 and 353 mg/dl¿ with the subject meter.The patient¿s normal blood glucose range is between ¿170 ¿ 200 mg/dl¿ and they manage their diabetes with unspecified insulin on a self-adjusting dose.The patient claimed that as a result of the alleged issue, they administered an increased dose of insulin (8 units) on (b)(6) 2022 at 8:00 pm.The following morning at 12:30 am, the patient claimed they woke up with symptoms of feeling ¿shaky, weak, disturbed, nervous, dizziness and changes of temperature¿.In response to the symptoms, the patient claimed they attended the doctor¿s office at 3:00 am and were advised by the nurse that their blood glucose levels were probably not high but low and were treated with a chocolate milkshake.After treatment, the patient claimed they measured their blood glucose with the subject meter using test strips from a new vial and a result of ¿167 mg/dl¿ was obtained.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca confirmed the test strip vial was intact and the test strips had been stored correct and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.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 administering insulin based on alleged inaccurate high results obtained with the subject meter.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC; 20 valley stream parkway; malvern PA 19355
• MDR Report Key: 14479163
• MDR Text Key: 292718119
• Report Number: 2939301-2022-03039
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4736062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/12/2022
• 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