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

Model Number	024-046
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Fatigue (1849); Hypoglycemia (1912); Diaphoresis (2452)
Date of Event	08/04/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 or Problem Description
On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra2 meter read inaccurately high compared to their feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began at 12:00 am on (b)(6) 2022.The patient reported obtaining alleged inaccurate high blood glucose readings of ¿300 and 350 mg/dl¿ with the subject meter.The patient reported that they manage their diabetes with a fixed dose of novorapid insulin three times a day before meals (20 units before breakfast, 25 units before lunch and 20 units before dinner).In response to the elevated readings, the patient reported administering their usual before dinner dose of insulin (20 units) then started to feel symptoms of ¿tired, hypo and sweating¿.The patient claimed they consumed food in response to their symptoms between 12:15 am and 12:20 am that morning.The patient denied that their blood glucose was tested with any other device.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter and the correct testing process was being followed.The cca confirmed the test strip vial was intact and the test strips had been stored correct and were not expired or opened past their discard date.The cca noted the patient did not have control solution available to perform a quality control test.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 administering insulin based on alleged inaccurate high results obtained with the subject meter.

• 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: 15255410
• Report Number: 3009698388-2022-00041
• Device Sequence Number: 6664061
• Product Code: NBW
• UDI-Device Identifier: 00353885011853
• UDI-Public: 00353885011853
• Combination Product (Y/N): N
• Initial Reporter Country: QA
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/18/2022

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: 024-046
• Device Catalogue Number: 02404601
• Device Lot Number: 1831526
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/18/2022
• 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: Unknown