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

Lot Number 4030769

Device Problem Calibration Error (1078)

Patient Problems Dysphasia (2195); Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6)2017, the lay user/patient contacted lifescan (lfs) alleging that his onetouch ultrasmart meter had a calcode issue ¿ the meter was ¿stuck on code 25¿.The complaint was classified based on customer care advocate (cca) documentation.The patient reported that the meter issue occurred on (b)(6) 2017 at 03:00am.The patient manages his diabetes with ¿insulin and metformin¿ and denied making any changes to his usual diabetes management routine in response to the alleged issue.The patient reported that at an unspecified time prior to the issue occurring he had developed symptoms of ¿sweaty and incoherent¿ and that he attempted to test his blood glucose using the subject meter, however was unable to because of the meter issue.The patient stated that he contacted the emergency medical services (ems) who tested his blood glucose using an ems meter, which gave a result of ¿35mg/dl¿ and he was treated with iv glucose.During troubleshooting the cca noted that when the patient was walked through setting the code the issue was resolved.Product was replaced and requested back.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event, and subsequently required medical intervention, after the alleged product issue began.

• Brand Name: OT ULTRASMART 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: 6826308
• MDR Text Key: 83832705
• Report Number: 3008382007-2017-22344
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K021819
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4030769
• Other Device ID Number: 1-AV-1131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/26/2017
• Device Age: 69 MO
• Date Manufacturer Received: 08/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2011
• 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: 84 YR
• Patient Weight: 134