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

Lot Number 4521855

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

Patient Problems Dizziness (2194); Sweating (2444); Alteration In Body Temperature (2682)

Event Date 05/29/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay user/patient contacted lifescan (lfs) (b)(4), onetouch ultramini meter was reading inaccurately high compared to other devices (freestyle, libre and guide), and their doctors device (guide).The complaint was classified based on information obtained from the customer service representative (csr) documentation.The patient reported that the alleged inaccuracy issue began at around 9 a.M., on (b)(6) 2020.The patient claimed obtaining a blood glucose result of ¿199 mg/dl¿ with the subject device, ¿49 mg/dl¿ with both the libre and guide devices and ¿48 mg/dl¿ with the freestyle meter, all performed within 30 minutes of each other.The patient manages his diabetes with self-adjusted insulin (2 units if his blood glucose level is less than 100 mg/dl and, 8 units if above 200 mg/dl) and he advised that in response the elevated reading obtained on the subject device, he administered 8 units of insulin.The patient advised that later that evening, at around 1 a.M., he developed symptoms of feeling ¿sweaty, dizzy and extreme cold¿.The patient reported he contacted his doctor who came and tested his blood glucose using their own device (guide), reportedly obtaining a result of ¿49 mg/dl¿.The patient denied receiving any treatment from his doctor and also advised that his medication remained unchanged.At the time of troubleshooting, the csr confirmed that the unit of measure was set correctly on the subject meter, that the patient was following the correct testing procedure and that an approved sample site was used to obtain the results.The csr established that the test strip vial was intact, that the test strips had been stored properly, were not open beyond their discard date and had not expired.The csr noted that at the time of the call, the patient did not have testing supplies available to test the subject device.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse consistent with an acute low blood glucose excursion after administering insulin based on the alleged elevated blood glucose reading obtained with the subject device.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; CH 6300
• MDR Report Key: 10122238
• MDR Text Key: 194152121
• Report Number: 2939301-2020-02650
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: AR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4521855
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 57 YR
• Patient Weight: 88