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

Lot Number 3500573

Device Problems Break (1069); Shelf Life Exceeded (1567); Improper or Incorrect Procedure or Method (2017)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Date 03/14/2016

Event Type  Injury  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation.If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Event Description

On (b)(6) 2016, the lay user/patient contacted lifescan (lfs) (b)(4) alleging a meter casing issue with her onetouch ultra2 meter.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that on (b)(6) 2016, she had inadvertently dropped the subject meter from her vehicle and then "ran over it, causing it to break catastrophically" and, as a result, was unable to test her blood glucose level.The patient manages her diabetes with oral medication, diet and/or exercise.She reported that after the issue occurred, she continued with her usual dose of medication (including sliding scale).She indicated that she ate a "normal supper" and administered 2 metformin 500mg tablets at around 6pm on (b)(6) 2016.She claimed that on the morning of (b)(6) 2016, she woke up with symptoms of "shakiness" which she self-treated by eating a banana.At the time of troubleshooting, the csr noted that the meter had not been used for the first time.Based on the information provided, there was misuse of the product and the entire unit was broken.The csr also noted that the patient's test strips had expired in (b)(6) 2015.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of hypoglycemia after the alleged casing issue began.

Manufacturer Narrative

Follow-up # 1.The lay user/patients meter has been returned and evaluated by lifescan product analysis with the following findings: the meter failed testing.The reported issue was confirmed.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

Further analysis was not possible for the returned meter due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.On (b)(6) 2020, lfs received notification from the fda that this supplemental was on-hold and had not been successfully received by the agency.Lfs has been engaged with the fda since (b)(6) 2020, to agree upon remediation of the on-hold issue.On (b)(6) 2020, the world health organization (who) declared the covid-19 outbreak as a global pandemic.In line with final guidance published by the fda in (b)(6) 2020, entitled 'postmarketing adverse event reporting for medical products and dietary supplements during an influenza pandemic'; lfs has agreed late reporting of all on-hold supplementals.This submission is included as part of that agreement.

• 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
• MDR Report Key: 5515857
• MDR Text Key: 40833892
• Report Number: 2939301-2016-13780
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3500573
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2016
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/14/2016
• Device Age: 54 MO
• Date Manufacturer Received: 04/18/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 45