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 Loss of consciousness (2418); Diaphoresis (2452); Alteration in Body Temperature (4568)

Event Date 09/19/2022

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.

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.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 ¿194 mg/dl¿ on the subject meter.The patient manages her diabetes with novolog insulin (3 units, self-adjusting dose) and the reporter informed the cca that his mother increased her insulin intake by 8 units in response to the high reading.The reporter stated that after his mother took the extra insulin she went to rest and when the son checked on her, she ¿was hot, sweaty and unresponsive¿.The son called 911 and the emergency medical services (ems) tested the patient¿s blood glucose and received a reading of ¿43 mg/dl¿ on an unspecified lab device.The reporter claimed that the reading was taken between 10 and 30 minutes after the alleged inaccurate reading obtained at 8 pm and he denied that the patient had taken any food or medication in between readings.The patient was treated by an hcp with iv glucose in the emergency room (er) after they received the reading of ¿43 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 developed symptoms suggestive of a serious injury adverse event after taking an increased dose of 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 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: 15547517
• MDR Text Key: 301239281
• Report Number: 3009698388-2022-00051
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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
• Date Manufacturer Received: 09/23/2022
• 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): Hospitalization; Life Threatening
• Patient Sex: Female