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

Lot Number	4356434
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	Shaking/Tremors (2515)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that she was obtaining erratic results, on her onetouch ultra mini meter.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the issue first began on (b)(6) 2018, alleging that she obtained inaccurate readings of ¿496, 107, 121 and 117 mg/dl¿ on the subject meter, the tests were performed greater than 20 minutes of each other.The patient reported that she manages her diabetes with oral medication, diet and exercise and made no changes to her normal routine.The patient reported that 10 days after the meter issue began, she developed symptoms of ¿shakiness¿.She confirmed that no treatment was received or required.During troubleshooting, the csr noted that the subject meter was set to the correct unit of measure, and an approved sample site to obtain the blood samples.Csr noted that the vial was not cracked or broken, the test strips had been stored correctly and were not passed their expiry date.The patient did not have control solution.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms of a serious injury adverse event, while using the product, and the alleged meter issue could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRAMINI 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: 7738103
• Report Number: 3008382007-2018-02181
• Device Sequence Number: 1398660
• Product Code: NBW
• UDI-Device Identifier: 00353885000512
• UDI-Public: 00353885000512
• Combination Product (Y/N): Y
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K061118
• 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): 07/27/2018

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: 4356434
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2018
• Initial Report FDA Received Date: 08/01/2018
• 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: 58 YR
• Patient Weight: 78