MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4529825

Device Problem Device Handling Problem (3265)

Patient Problems Hypoglycemia (1912); Collapse (2416)

Event Date 08/07/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a reporter for the patient (the patient¿s son) contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ultra2 meter displayed inaccurately high results compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The reporter alleged that the subject meter was reading inaccurately around 5pm on (b)(6) 2019, when the patient obtained an alleged inaccurately high blood glucose result of ¿78 mg/dl¿.The reporter did not know the name(s) of the medication the patient takes to manage her diabetes but thought it might be ¿glypto 2.5 mg¿.The reporter indicated that after obtaining the reading, he gave the patient ¿orange juice¿.He reported that 5-10 minutes later, the patient ¿collapsed¿.He stated that 911 was contacted around 6pm on (b)(6) 2019, and a blood glucose result of ¿37 mg/dl¿ was obtained on the emergency medical service meter (which the reporter compared to the reading on the subject meter about an hour earlier).Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The reporter stated that the patient received treatment of a glucagon injection from the paramedics.At the time of troubleshooting, the cca noted that the subject meter was set to the correct unit of measure and an approved sample site had been used to obtain the blood samples.Education was provided by the cca and replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed a sign and symptom suggestive of a serious injury adverse event requiring medical intervention, after obtaining an alleged inaccurately high result on the subject meter.

• Brand Name: OT ULTRA2 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: 8886640
• MDR Text Key: 154094757
• Report Number: 3008382007-2019-03309
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K053529
• 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: 08/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4529825
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 08/10/2019
• 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