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 Hypoglycemia (1912); Dysphasia (2195); Shaking/Tremors (2515)

Event Date 09/01/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy occurred on (b)(6) 2022.The patient claimed obtaining blood glucose readings of ¿479 to 488 mg/dl¿ with the subject meter, performed within 20 minutes each other.The patient stated they manage their diabetes with humalog mix 75/25 insulin and administered an increased dose of insulin (20 units instead of 7 units) in response to the alleged issue.90 minutes after the insulin was administered, the patient started to develop symptoms of ¿arms shaking and slower speech¿.As a result of the symptoms, the patient claimed they went to the hospital where their blood glucose measured ¿39 mg/dl¿ on the hospital meter.It was not specified what treatment the patient received.The patient indicated they were hospitalized for 3 days.During troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the same approved sample site was used for testing.The cca confirmed the test strip vial was intact and the test strips had been stored correctly and were not expired or opened past their discard date.The cca noted that the patient did not have control solution available to perform a quality control test.The patient declined to have the products replaced.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering an increased dose of insulin based on alleged inaccurate results obtained with the subject meter.

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.

• 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: 15415043
• MDR Text Key: 299833010
• Report Number: 3009698388-2022-00045
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2022
• 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: 4764366
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/07/2022
• 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): Life Threatening; Required Intervention; Hospitalization