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

Lot Number	3920485
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2017, the lay user/patient contacted lifescan (lfs) to report that hardware was missing from her onetouch verioiq meter kit.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that about 6 months prior to contacting lfs, she had not received the usb cable/ac adaptor with the onetouch verioiq starter kit.The patient manages her diabetes with oral medication, diet and/or exercise.She denied making any changes to her usual diabetes management routine following the start of the alleged issue.She reported that one morning, 5 days prior to contacting lfs, she developed symptoms of ¿dizzy, weak, feels like will pass out and headache¿.She denied receiving any treatment for her symptoms.At the time of troubleshooting, the cca confirmed with the patient that the closure seal on the packaging had been intact prior to opening.The cca educated the patient on the correct box contents and the patient reported that the usb cable/ac adaptor had been missing from the starter kit.The issue remained unresolved.The patient¿s products were requested back for investigation and replacement products, including a cable and adaptor, were sent to the patient.Based on the information provided, there is no indication that the subject meter caused or contributed to the development of signs or symptoms that meet lfs criteria for a serious injury reportable adverse event.However, this complaint is being reported as a malfunction because the alleged product issue was not resolved during troubleshooting.

• Brand Name: OT VERIO IQ 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: 6502681
• Report Number: 3008382007-2017-18231
• Device Sequence Number: 339934
• Product Code: NBW
• UDI-Device Identifier: 00353885007702
• UDI-Public: (01)00353885007702
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110637
• 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): 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Lot Number: 3920485
• Other Device ID Number: 1-1960Z86
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/05/2017
• Device Age: 29 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1