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

Lot Number 4517378

Device Problem Device Handling Problem (3265)

Patient Problems Fainting (1847); Low Blood Pressure/ Hypotension (1914); Dizziness (2194)

Event Date 01/10/2020

Event Type  Injury  

Event Description

On january 13, 2020, the lay-user/patient contacted lifescan (lfs) argentina, alleging that his onetouch ultramini meter read inaccurately erratic.The complaint was classified based on the customer service agent (csa) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2020 at 10:54 pm when he obtained a blood glucose result of ¿249 mg/dl¿ with the subject meter.The patient manages his diabetes with insulin nph (20 units in the morning, 25 units at noon, 30 units at night) and fast-acting insulin (correction dose based on blood glucose results).The patient claimed that in response to the alleged inaccurate result, he took 30 units of insulin nph and a correction dose of 6 units of fast-acting insulin.The patient stated that he began to eat dinner then started feeling ¿dizzy and low pressure.¿ in response to the symptoms, the patient claimed he tested his blood glucose with the subject meter and obtained a result of ¿149 mg/dl¿ then ¿passed out.¿ the patient reported that when he woke up, he tested his blood glucose with the subject meter using another vial of strips and obtained a result of ¿42 mg/dl¿ at 11:52 pm.The patient reported treating himself with liquid with sugar to raise his blood glucose and continued to monitor until he obtained a result of ¿150 mg/dl.¿ during troubleshooting, the csa confirmed that the unit of measure was set correctly on the subject meter and that the same approved sample site was used for testing.The csa noted that the patient did not have control solution available to test the subject meter.Replacement products were sent to the patient.This complaint is being reported because patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after taking a correction dose of insulin based on alleged inaccurate result obtained with the subject meter.

• 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
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; GB IV2 3ED
• Manufacturer Contact: michelle karim ; beechwood park north; inverness IV2 3-ED ; GB IV2 3ED ; 1463383679
• MDR Report Key: 9595558
• MDR Text Key: 175463457
• Report Number: 3008382007-2020-03841
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008136
• UDI-Public: 00353885008136
• Combination Product (y/n): Y
• Reporter Country Code: AR
• PMA/PMN Number: K061118
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4517378
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/13/2020
• 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