MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number	4191419
Medical Device Problem Code	Loss of Power (1475)
Health Effect - Clinical Codes	Fatigue (1849); Nausea (1970); Seizures (2063)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter would not turn on.The complaint was classified based on information obtained from the customer service representative (csr) documentation and on additional information obtained by the medical surveillance specialist (mss) after reviewing the call recording, since the patient did not wish to provide additional information when contacted.The patient reported that the alleged issue began 2 months prior to contacting lfs; however, she was unable to recall the specific date.It is not known how the patient manages her diabetes or what changes, if any, she made to her usual diabetes management routine in response to the alleged issue.The patient reported that she became ¿fatigued, nauseous and tired¿ an unknown time before the alleged issue occurred and due to being unable to test, the patient stated that she had a ¿diabetic seizure¿; however, she was unable to provide the date/time this happened.The patient stated that on an unknown date, she was rushed to the emergency room (er); however, she was unable and/or unwilling to confirm what treatment, if any, she received.The patient was unable and/or unwilling to confirm if her blood glucose was tested on another device.At the time of troubleshooting, the csr noted that the meter was not being used for the first time and there was no misuse of the product.The csr established that the patient was using the correct test strips but the meter would not power on when a test strip was inserted per owner¿s manual or when the power button was pressed.Based on the information provided, the meter¿s battery did not need to be replaced.The issue could not be resolved with training.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 the alleged issue occurred.

• Brand Name: OT ULTRA2 METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7141485
• Report Number: 3008382007-2017-23717
• Device Sequence Number: 1108953
• Product Code: NBW
• UDI-Device Identifier: 00353885008853
• UDI-Public: 00353885008853
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Other Caregivers
• Type of Report: Initial
• Report Date (Section B): 12/10/2017

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: 4191419
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/10/2017
• Device Age: 36 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2017
• Initial Report FDA Received Date: 12/22/2017
• 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
• Patient Age: 47 YR
• Patient Weight: 63