MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	4469121
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	Dysphasia (2195)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2019, a reporter for the patient contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra2 meter displayed error 3 messages.The complaint was classified based on the customer care advocate (cca) documentation following a review of the call by a senior cca and a follow-up call with the reporter.The reporter stated that starting around 5pm on (b)(6) 2019, when the patient attempted to test her blood glucose level, the meter showed error 3 messages.The patient manages her diabetes with 80 units of tresiba insulin (no adjustments).The reporter denied that the patient made any changes to her usual diabetes management routine as a result of the alleged issue.The reporter stated that an unknown time later, the patient developed ¿slurred speech¿; the reporter did not know if this was associated with a high or low blood glucose excursion.The reporter denied that the patient received any treatment for her symptom.During troubleshooting, the reporter described the correct testing steps.The cca walked the reporter/patient through a retest, but the issue remained unresolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a symptom suggestive of a serious injury adverse event, after being unable to obtain a blood glucose reading on the subject meter and continuing with her usual diabetes management routine.

• Brand Name: OT ULTRA2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8892252
• Report Number: 3008382007-2019-03342
• Device Sequence Number: 1606729
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• 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): 08/07/2019

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: 4469121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2019
• Initial Report FDA Received Date: 08/14/2019
• 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