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

Lot Number	3618434
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Blurred Vision (2137); Shaking/Tremors (2515)
Date of Event	04/03/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) usa, alleging a sample draw issue with his onetouch verio test strips.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged strip issue began on (b)(6) 2017.The patient informed the csr that he manages his diabetes with insulin (self-adjuster) and denied making any changes to his usual diabetes management routine in response to the alleged issue.The patient reported that on (b)(6) 2017, 3 weeks after the alleged issue began, he developed symptoms of ¿shaky hands and blurry vision.¿ the patient denied receiving medical treatment.During troubleshooting, the csr confirmed the patient was following the correct testing process.The csr noted the test strip only partially filled after a sample was applied.The products involved in the complaint were requested back for investigation and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms that meet lfs¿ criteria for a serious injury reportable adverse event, after the alleged product issue began.

• Brand Name: OT VERIO TEST STRIPS
• 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: 6521340
• Report Number: 3008382007-2017-19256
• Device Sequence Number: 13652383
• Product Code: NBW
• UDI-Device Identifier: 00353885009751
• UDI-Public: (01)00353885009751(10)3618434(17)151231
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K093745
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 04/12/2017

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?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 3618434
• Other Device ID Number: 1-SPA5A5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2017
• Initial Report FDA Received Date: 04/26/2017
• 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: 59 YR
• Patient Weight: 77