MAUDE Adverse Event Report: LIFESCAN INC. OT ULTRA TEST STRIP; GLUCOSE MONITORING SYS/KIT

Model Number 022-895

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hyperglycemia (1905)

Event Date 07/22/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs) usa, alleging that her one touch ultra test trips were ¿messed up¿ and ¿didn t register¿.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained during a follow-up call with the patient.The patient did not report when the alleged strip issue started.During the follow-up call the patient stated that she manages her diabetes with an insulin pump and pills (type and dose unspecified) and indicated that she did not made any changes to her diabetes management regimen in response to the alleged issue.The patient informed the agent that due to the alleged strip issue her blood sugar levels went up to 500 mg/dl for three days.During the follow-up call the patient confirmed that she was able to receive these readings with the subject test strips.The patient did not report any symptoms and denied receiving any medical treatment due to the alleged issue.The cca was not able to troubleshoot the problem during the initial call and the patient was unable to read the lot number.Replacement test strips were sent to the patient.This complaint is being reported because the patient reportedly developed signs suggestive of a serious injury adverse event after the alleged product issue began.There is insufficient information to rule out the contribution of the subject test strips to the event.

• Brand Name: OT ULTRA TEST STRIP
• 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: 15214728
• MDR Text Key: 297763240
• Report Number: 3009698388-2022-00038
• Device Sequence Number: 1
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043197
• 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: 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 022-895
• Device Catalogue Number: 022-895
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2022
• 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
• Patient Sex: Female