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

Device Problem Peeled/Delaminated (1454)

Patient Problem Shaking/Tremors (2515)

Event Date 01/13/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, the patient contacted lifescan (lfs) usa alleging that his one touch ultra test strips were ¿peeling¿.The complaint was classified based on the customer care advocate (cca) documentation.The patient reported that on an unknown time prior to contacting lfs he became aware that his onetouch ultra test strips were peeling and as a result he was unable to test.It is unclear how the patient manages his diabetes.However, the patient reported that he increased his dose of medication by an unspecified amount in response to the alleged product issue.The patient stated that on (b)(6) 2019 at around 8:30pm, ¿10 minutes¿ after the alleged product issue began, he developed the symptom of ¿shakes and tremors¿.The patient reported self-treating with ¿sugar tabs and felt okay afterwards¿.The patient denied using another device to obtain a blood glucose result.At the time of troubleshooting, the cca determined that there was more than one test strip from the vial that was affected.The issue occurred before inserting the test strip.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and/or symptoms that meet lfs¿ criteria for a serious injury adverse event after the alleged product issue began.The symptoms and treatment received suggests that the patient¿s condition deteriorated as a result of not being able to test their blood glucose.

• Brand Name: OT ULTRA TEST STRIPS
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8255897
• MDR Text Key: 133357391
• Report Number: 3008382007-2019-00187
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K043197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/14/2019

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/14/2019
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 01/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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