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

Lot Number 4091607

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Type  Injury  

Event Description

On (b)(6) 2017, the reporter (wife) for the patient contacted lifescan (lfs) alleging that his onetouch ultra2 meter was reading inaccurately erratic.The complaint was classified based on the customer care advocate (cca) documentation and additional information obtained when cca reviewed the original call.The reporter stated that the alleged product issue began several weeks prior to contacting lfs.The reporter stated that ¿about a week ago¿ the patient obtained alleged inaccurate erratic results of ¿263, 323 and 270mg/dl¿ on the subject meter performed less than 20 minutes apart.Based on statistical methodology, the calculated difference between these results falls within lfs¿ criteria for precision.The patient manages his diabetes with insulin (self-adjuster) including apidra sliding scale 7-20 units, levemir 15 units and reportedly continued with his usual diabetes management routine, including sliding scale as a result of the alleged product issue.The reporter stated that the patient developed symptoms of ¿fever and infection¿ as a result of his high blood glucose readings 4 - 6 weeks after the alleged product issue began.The reporter stated that on (b)(6) 2017, the patient attended er and was treated with fluids, insulin and surgery to drain an abscess.Blood glucose results were obtained on the er meter; however, the reporter was unable to recall the results.At the time of trouble shooting, the cca confirmed that the subject meter was set to the correct unit of measure and the sample was taken from an approved sample site.The patient¿s products were replaced and requested back for evaluation.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury reportable adverse event after the alleged product issue began and subsequently received medical intervention from a healthcare professional after the alleged device issue occurred.

• 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: 6379303
• MDR Text Key: 69095788
• Report Number: 3008382007-2017-10888
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: (01)00353885008372
• 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: 02/22/2017

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
• Device Operator: Lay User/Patient
• Device Lot Number: 4091607
• 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: 02/22/2017
• Device Age: 11 MO
• Initial Date Manufacturer Received: 02/22/2017
• Initial Date FDA Received: 03/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2016
• 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 Age: 53 YR
• Patient Weight: 104