MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

Device Problem Device Alarm System (1012)

Patient Problems Fatigue (1849); Blurred Vision (2137)

Event Date 12/12/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, lay user/patient contacted lifescan (lfs) usa, alleging that their onetouch ultra2 meter was continually displaying the ¿apply sample¿ message.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The patient was unable to provide the exact date that the alleged issue began but advised that it was a ¿few days¿ prior to contacting lfs.The patient manages her diabetes with oral medication (rybelsus, unspecified dose) and she advised that she continued to take her medication as normal and denied making any changes to her usual diabetes management regimen in response to the alleged issue.The patient reported than an unspecified time after the alleged issue began, she developed symptoms of feeling ¿low in energy¿ and had ¿blurry eyes.¿ the patient advised that on (b)(6) 2020, she self-treated her symptoms by drinking some orange juice.The patient denied testing her blood glucose on another device.At the time of troubleshooting, the cca established that the device was not being used for the first time and that the patient was using the correct test strips.The patient was unable and/or unwilling to describe their testing steps in order for the cca to confirm if the patient was following the correct testing procedure as outlined in the owner¿s booklet.The cca walked the patient through resolving the issue; however, noted that the issue remained unresolved.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 for an acute low blood glucose excursion after the alleged issue with the subject device began.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan (lfs) product analysis with the following findings: the meter has passed performance testing with no faults found.The reported issue could not be confirmed.A device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.In addition, the serial number the patient provided ((b)(6) ) during the initial call was found to be incorrect.The correct serial number is (b)(6) and was obtained on product return; the serial # in section d4 has therefore been updated to reflect correct information.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11086063
• MDR Text Key: 224096265
• Report Number: 3008382007-2020-04087
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4664141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 03/18/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention