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

Model Number	021-098
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Codes	Syncope (1610); Sweating (2444)
Date of Event	05/14/2020
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 high compared to his feelings and/or normal readings.The complaint was classified based on the customer service agent (csa) documentation.The patient reported that the alleged meter inaccuracy occurred on (b)(6) 2020 at 2:25 am when he obtained an alleged inaccurate high result of ¿96 mg/dl¿ with the subject meter.The patient manages his diabetes with lantus insulin on a self-adjusting dose.The patient denied making any changes to his usual diabetes management regimen as a result of the alleged issue.The patient claimed that a few minutes after the alleged issue occurred, he started to ¿feel like passing out and was sweating.¿ in response to the symptoms, the patient claimed he self-treated with a glucose tablet and a boost nutritional drink.The patient denied using any other device to test his blood glucose.At the time of troubleshooting, the csa confirmed the unit of measure was set correctly on the subject meter.The csa noted the patient did not have control solution available to perform a quality control test.The csa noted the patient was testing with test strips that had expired.Replacement products were 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 inaccuracy 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: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 10060767
• Report Number: 3008382007-2020-03932
• Device Sequence Number: 3536065
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (Y/N): Y
• 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): 05/14/2020

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: 4189003
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/15/2020
• 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; Required Intervention