MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUOCSE MONITORING SYS/KIT

Model Number	021-098
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Anxiety (2328); Diaphoresis (2452)
Date of Event	09/16/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter read inaccurately erratic.The complaint was classified based on the customer care agent (cca) documentation, since the patient was unable to be reached by phone to obtain additional information.The patient reported that the alleged meter inaccuracy began on the morning of (b)(6) 2020.The patient claimed he tested his blood glucose with the subject meter and obtained readings of "236, 269 and 93 mg/dl" at 8:00 am, 9:00 am, and 9:01 am respectively.The patient stated that he does not take any medication to manage his diabetes and denied making any changes to his usual diabetes management routine in response to the alleged inaccurate results.The patient reported that after 9:00 am on september 16, 2020, he developed symptoms of "anxiety, clammy and probably raised blood pressure." the patient denied receiving medical treatment.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.Replacement product was sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA 2 METER
• Common Device Name: GLUOCSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug, 6300 ; SZ 6300
• MDR Report Key: 10648520
• Report Number: 3008382007-2020-04022
• Device Sequence Number: 17025210
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K053529
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/16/2020

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: 021-098
• Device Catalogue Number: 021-098
• Device Lot Number: 4631301
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2020
• Initial Report FDA Received Date: 10/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening