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

Model Number	022-895
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/22/2022
Type of Reportable Event	Serious Injury
Event or Problem 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
• Common Device Name: 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
• Report Number: 3009698388-2022-00038
• Device Sequence Number: 17543683
• Product Code: CGA
• UDI-Device Identifier: 00353885009713
• UDI-Public: 00353885009713
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K043197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 022-895
• Device Catalogue Number: 022-895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2022
• Initial Report FDA Received Date: 08/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female