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

Lot Number	4095675
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Codes	Dyspnea (1816); Fatigue (1849)
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6), a reporter for the patient contacted lifescan (lfs) usa, to report that hardware may have been missing from the patient¿s onetouch verioiq starter kits.The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained when the reporter was contacted with follow-up questions.The reporter stated that the patient obtained two onetouch verioiq starter kits at 4pm on either (b)(6).She stated that the usb cable and ac adaptor may not have been included with the kits; she indicated that the kits were sealed and she was unsure if the hardware was lost, or had been missing from the kits.The patient manages her diabetes with insulin which she self-adjusts.The reporter denied that the patient had made any changes to her usual diabetes management routine after the start of the alleged issue.She reported that because the patient was unable to charge the meter and obtain a blood glucose result, she developed symptoms of ¿tiredness and respiration problems¿ which the reporter associated with a high blood glucose excursion.She reported that the patient was taken to hospital where she received treatment of lantus and humalog insulin and other unknown medications.At the time of troubleshooting, the cca noted that the closure seal on the packaging was intact prior to opening.The cca educated the reporter on the correct box contents but the reporter was unable to confirm whether product was missing or whether it had subsequently been lost.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received hcp treatment/medical intervention for an acute high blood glucose excursion, after alleging that product may have been missing from the onetouch starter kits.

• 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: 7001976
• Report Number: 3008382007-2017-23110
• Device Sequence Number: 16518120
• Product Code: NBW
• UDI-Device Identifier: 00353885007719
• UDI-Public: (01)00353885007719
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 10/28/2017

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: 4095675
• Other Device ID Number: 1-1960Z86
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/28/2017
• Device Age: 14 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2017
• Initial Report FDA Received Date: 11/04/2017
• 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; Required Intervention