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

Model Number	021-924
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Vertigo (2134)
Date of Event	06/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, the reporter contacted lifescan (lfs) peru, alleging that her grandmother¿s onetouch ultra mini meter was reading inaccurately high compared to another meter.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call, after review of the call and on additional information obtained during a follow-up call with the patient on (b)(6) 2021.The reporter claimed that the alleged issue began at 9 a.M., on (b)(6) 2021.The reporter advised that her grandmother felt ¿dizzy¿ and obtained a blood glucose reading of ¿221 mg/dl¿ on the subject meter after she developed the symptom.The patient manages her diabetes with insulin (type and dose unspecified) and the reporter stated that in response to the alleged issue, they called the doctor.The reporter mentioned that her grandmother also administered 18 mg of insulin at an unspecified time after the alleged issue occurred.Approximately 12 hours later, around 10 p.M.That same day, the doctor came by and obtained a blood glucose reading of ¿61 mg/dl¿ on a hospital meter.During the follow-up call, the patient confirmed that the doctor treated her with dextrose and two other types of medication (patient does not remember which).During troubleshooting, the cca confirmed that the unit of measure was set correctly on the subject meter.The cca informed the reporter of the patient on the option of comparing the meter to a lab meter and explained how to perform a control solution test.The cca walked the reporter through a hard reset of the meter after the reporter mentioned that the meter sometimes takes longer to show a reading.A control solution has been sent to the patient.Even though the patient developed symptoms prior to the product issue, this complaint is being reported because the patient took an increased dose of insulin based on an alleged inaccurate high result obtained with the subject meter.The patient reportedly received hcp treatment for an acute low blood glucose excursion while using the product and there is evidence of delay in treatment due to the alleged inaccurate high result.
Additional 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.A device history record review could not be performed as the meter serial number was unavailable.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 MINI METER
• Common Device Name: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12112568
• Report Number: 3008382007-2021-04182
• Device Sequence Number: 4600706
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (Y/N): Y
• PMA/510(K) Number: K061118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 021-924
• Device Catalogue Number: 021-924
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/28/2021
• Supplement Date Received by Manufacturer: 06/28/2021
• Initial Report FDA Received Date: 07/02/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention