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

Lot Number 4460907

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

Patient Problems Blurred Vision (2137); Weakness (2145); Collapse (2416)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter displayed inaccurate results compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation following a review of the call by a senior cca.The patient reported that he had been getting incorrect readings for about a week prior to contacting lfs; however, no results were provided for this time.He stated that on the night of (b)(6) 2019, he obtained an alleged inaccurate result on the subject meter of ¿68 mg/dl¿ compared to ¿38 mg/dl¿ on a paramedic¿s meter.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 patient manages his diabetes with humulin 70/30 insulin and also takes other non-diabetes medications.He reported that at 5pm on (b)(6) 2019, he ate dinner and administered 32 units of humulin along with his other medications.He reported that several hours later, around 11pm, he developed symptoms of ¿blurry vision, really weak and collapsed¿.He stated that when he collapsed, he hit the sink, then tried to stand up but collapsed again and hit the bath tub then tried again but collapsed and hit the toilet bowl sustaining bruises to his body.He reported that he called 911 and when the paramedics arrived they obtained the result of ¿38 mg/dl¿ on their emergency medical services meter.He stated that to treat his symptoms, the paramedics squeezed 2 tubes of liquid glucose into his mouth which brought his blood sugar level up to ¿112 mg/dl¿.At the time of troubleshooting, the cca noted that the patient¿s meter was set to the correct unit of measure.The patient confirmed that his test strips were within expiry date and had been stored correctly.He described the correct testing steps and confirmed that an approved sample site had been used to obtain the blood samples.The patient did not have control solution to test the meter and test strips.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed a sign and symptoms suggestive of a serious injury adverse event requiring medical intervention, after obtaining alleged inaccurate blood glucose results 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: 8242851
• MDR Text Key: 132910791
• Report Number: 3008382007-2019-00156
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• 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: 01/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4460907
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/06/2019
• Device Age: 167 MO
• Date Manufacturer Received: 01/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2005
• 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