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

Lot Number 4276914

Device Problem Calibration Error (1078)

Patient Problems Dizziness (2194); Collapse (2416)

Event Date 12/11/2017

Event Type  Injury  

Event Description

On (b)(6) 2017, a reporter for the lay user/patient contacted lifescan (lfs) usa, alleging a calcode issue with the patient¿s onetouch ultramini meter.The complaint was classified based on information obtained from the customer service representative (csr) documentation.The reporter advised that at around 3 p.M., on (b)(6) 2017, they attempted to test the patient¿s blood glucose with the subject device and noted that it was displaying an incorrect calcode; calcode 26 as opposed to calcode 25.The patient manages her diabetes with oral medication (metformin and glipizide, dosages not reported) and the reporter advised that the patient continued to take her usual dose of medication in response to the alleged issue.The reporter advised that immediately after the alleged issue occurred, the patient became ¿dizzy and fell down on the ground.¿ the reporter stated that she contacted the emergency medical services (ems) for assistance and upon their arrival, they provided the patient with food and/or drink and re-tested her blood glucose using the subject device; however, the reporter did not provide the result obtained.At the time of troubleshooting, the csr walked the reporter through changing the code on the subject device and noted that the issue was resolved.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after the alleged issue began.

• Brand Name: OT ULTRAMINI 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: 7132815
• MDR Text Key: 95321687
• Report Number: 3008382007-2017-23657
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885011464
• UDI-Public: 00353885011464
• Combination Product (y/n): N
• PMA/PMN Number: K061118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4276914
• Other Device ID Number: 1-AGJ5R2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/14/2017
• Device Age: 33 MO
• Date Manufacturer Received: 12/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2015
• 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: 90 YR
• Patient Weight: 65