MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 3595539

Device Problems Shelf Life Exceeded (1567); High Test Results (2457)

Patient Problem Sweating (2444)

Event Date 12/14/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient contacted lifescan (lfs) alleging that his onetouch ultra 2 meter was reading inaccurately high compared to feelings /normal results.The complaint was classified based on the customer care advocate (cca) documentation.The reporter alleged that the inaccuracy began on "(b)(6) 2015, 7- 8:00pm" the patient stated that he obtained an alleged inaccurate high blood glucose result of "199mg/dl" on the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient reported that he does not take medications to manage his diabetes and around 7-7:30pm he exercised as a result of the alleged product issue.The patient claimed that "30 minutes" after the alleged product issue began he developed symptoms of "sweaty" the patient reported that on (b)(6) 2015, 8:00am he made a visit to his doctor and was prescribed "half a pill", type and dosage was unknown.At the time of trouble shooting, the cca confirmed the subject meter was set to the correct unit of measure.However the patients test strips had passed their expiry date.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly suffered symptoms suggestive of a serious injury after the alleged product issue began.

• Brand Name: OT ULTRA2 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: 5326156
• MDR Text Key: 34323299
• Report Number: 2939301-2015-55683
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• 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: 12/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3595539
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/15/2015
• Device Age: 23 MO
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2014
• 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
• Patient Age: 57 YR
• Patient Weight: 77