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

Model Number 021-105

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problems Hypoglycemia (1912); Visual Impairment (2138); Dizziness (2194); Shaking/Tremors (2515)

Event Date 08/07/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay-user/patient contacted lifescan (lfs) (b)(4), alleging that her (b)(6) meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on the morning of (b)(6) 2021 when she obtained an alleged inaccurate high blood glucose reading of ¿20.7 mmol/l¿ with the subject meter.The patient stated that she manages her diabetes with onglyza 5 mg, 1 pill every morning.In response to the elevated reading, the patient reported taking her usual dose of onglyza and symptoms of ¿dizziness, body shaking and eyesight problem¿ began to develop that morning.The patient reported obtaining further readings of between ¿20.0 to 25.0 mmol/l¿ with the subject meter on (b)(6) 2021 and contacted her doctor who prescribed additional medication (diabeta 5mg, 1 pill; metformin, 1 pill).The patient claimed she continued to obtain elevated readings with the subject meter after taking the additional medication and on (b)(6) 2021, whilst on vacation at the doctor¿s family house, her symptoms worsened while swimming.The patient claimed her blood glucose tested ¿3.0 mmol/l¿ on the doctor¿s meter and was advised to eat some food.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged inaccuracy issue began.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

This supplemental is being sent to include the investigation conclusion code that was omitted from the h6 field of the initial report.The investigation conclusion code that should have been included at the time of submission of the initial report is: 67.If lifescan obtains additional information regarding this complaint, a follow up report will be submitted.At this time, lifescan considers this matter closed.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, 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.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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 12346035
• MDR Text Key: 267444001
• Report Number: 3008382007-2021-04214
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: CA
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Date Manufacturer Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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