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

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

Patient Problem Shock, Insulin (2264)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4) alleging that the patient¿s onetouch ultramini enhanced meter was reading inaccurately high compared to his feelings and/or normal readings.The following complaint was classified based on the customer service representative (csr) documentation and information obtained during a follow-up call with the patient.The patient alleged that the product issue began at an unspecified date and time.The patient stated that he obtained unspecified inaccurate high blood glucose readings with the subject meter compared to his feelings/normal result(s).Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.It was not reported how the patient usually manages his diabetes, however, he did report that he increased his dose of insulin (unspecified dosage) in response to the alleged issue.At an unspecified date and time after the alleged product issue occurred, the patient reportedly went into ¿an insulin shock¿.It is not reported if the patient received any medical treatment/intervention in response to the issue.The patient did confirm that he used another device to check his blood glucose level but did not specify the reading.During troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter and the csr noted that the patient did not have a control solution available to perform a quality control test.During the follow-up call with the patient, the patient clarified that he was using the correct test strips with the onetouch ultramini meter, but that the test strip carton contained a promotional sticker relating to verio product which initially caused confusion and therefore a replacement one touch verio flex meter kit was sent in error to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT ULTRAMINI ENHANCED METER
• 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: 8082084
• MDR Text Key: 127536556
• Report Number: 3008382007-2018-03159
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2018
• 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: 11/08/2018
• Date Manufacturer Received: 11/08/2018
• 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