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 Problem Dyspnea (1816)

Event Date 09/21/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the reporter (the son) of the lay user/patient contacted lifescan (lfs) usa, alleging that his mother¿s onetouch ultra 2 meter was reading inaccurately high compared to a calibrated lab method.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call and on additional information obtained after customer care reviewed the call recording.The reporter alleged that the product issue began on (b)(6) 2022 at 8 pm.The reporter claimed that the patient obtained a blood glucose reading of ¿184 mg/dl¿ on the subject meter.The patient manages her diabetes with novolog insulin (self-adjusting dose) and the reporter informed the cca that his mother increased her insulin intake by 8 units immediately after the reading on the subject meter.The reporter stated that after his mother took the extra insulin, she went to bed.At 4 am on (b)(6) 2022, the patient ¿could not breath¿ and her son took her to the emergency room (er).At the er the patient¿s blood glucose was tested and a reading of ¿31 mg/dl¿ on an unspecified lab device was obtained.The patient was treated by an hcp with iv glucose in the emergency room (er) after they received the reading of ¿31 mg/dl¿ on a lab device.During troubleshooting, the cca confirmed that the patient had used an approved sample site to obtain the blood samples.The cca educated the reporter on the use of control solution.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment for an acute low blood glucose excursion after the patient increased her insulin intake 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 pkwy; malvern PA 19355
• MDR Report Key: 15592109
• MDR Text Key: 301628303
• Report Number: 2939301-2022-03114
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• 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: 4770360
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female