MAUDE Adverse Event Report: LIFESCAN INC. OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	5726069
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Bruise/Contusion (1754); Hypoglycemia (1912); Syncope/Fainting (4411); Salivary Hypersecretion (4486)
Date of Event	10/05/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2024, a reporter for the lay user/patient contacted lifescan (lfs) united states, alleging that the patient¿s onetouch ultra2 meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The reporter stated that the alleged meter inaccuracy occurred on the night of october 5, 2024.The reporter claimed the patient obtained an alleged inaccurate high blood glucose reading of ¿500 mg/dl¿ with the subject meter.In response to the elevated reading, the reporter indicated that the patient took a shot of insulin (type/dose unspecified) then began ¿foaming and passed out¿.The reporter called an ambulance and when they arrived, the patient¿s blood glucose read ¿22 mg/dl¿ on the ambulance meter.The reporter indicated that the patient was given a glucagon injection and taken to hospital.The reporter stated that the patient was hospitalized for 3 days because "they didn't know why her sugar was up and down".The reporter also mentioned the patient was ¿bruised up¿ because of all the pricks she had received.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.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.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after administering treatment based on an alleged inaccurate high reading obtained with the subject meter.
Additional 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
• 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: 20518900
• Report Number: 3009698388-2024-00032
• Device Sequence Number: 18113099
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (Y/N): N
• PMA/510(K) Number: K053529
• 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): 10/23/2024

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 Lot Number: 5726069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 10/23/2024
• 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; Required Intervention; Hospitalization
• Patient Sex: Unknown