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

Lot Number 3862568

Device Problem Loss of Power (1475)

Patient Problem Headache (1880)

Event Date 09/01/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that his onetouch select simple meter would not power on.The complaint was classified based on customer service representative (csr) documentation.The patient reported that the alleged meter power issue began on (b)(6) 2018 at 10 am.The patient informed the csr that he manages his diabetes with 45 units of nph insulin and metformin (dose unspecified) twice daily and reported continuing with his usual diabetes management routine after the power issue began.The patient reported that after 15 days of the alleged issue starting, he developed a symptom of ¿headache¿.The patient also reported going to the emergency room (er) on (b)(6) 2018 at 8 am and had his blood glucose measured with the er meter and obtained a result of 620 mg/dl at 9 am.The patient reported receiving iv fluids as treatment.At the time of troubleshooting, the csr noted the subject meter was not being used for the first time and there was no indication of misuse to the device.The csr confirmed the correct test strips were being used for testing and based on the information provided, the batteries did not need to be replaced.The alleged product issue was not resolved with troubleshooting.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after he was unable to test his blood glucose with the subject meter due to the alleged power issue.

• Brand Name: OT SELECT SIMPLE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8031838
• MDR Text Key: 125910091
• Report Number: 3008382007-2018-03060
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 3862568
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/27/2018
• Device Age: 39 MO
• Date Manufacturer Received: 10/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 40 YR
• Patient Weight: 35