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

Lot Number 3425531

Device Problem Device Handling Problem (3265)

Patient Problems Headache (1880); Hypoglycemia (1912); Shaking/Tremors (2515); Cognitive Changes (2551); Confusion/ Disorientation (2553)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

Similar complaints for this issue were trended for the test strip lot.It was concluded that the number of complaints for the lot did not breach thresholds indicative of a systemic issue.

Event Description

On (b)(6) 2022, the lay-user/patient contacted lifescan (lfs), alleging that their onetouch ultra mini meter read inaccurately high compared to another device (emergency medical services meter).The complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2022.The patient reported obtaining blood glucose readings of ¿121 mg/dl¿ with the subject meter and ¿20 mg/dl¿ on the other device, performed more than 30 minutes apart.The patient manages their diabetes with a once weekly non-insulin injection and oral medications.It was not reported if the patient made any changes to their usual diabetes management regimen as a result of the alleged issue.The patient reported developing symptoms of ¿loss of awareness, started to act funny, loss of memory, shaky and headache¿ on (b)(6) 2022.The patient claimed they were treated by the emergency medical services (ems) with iv glucose and food.The patient claimed their blood glucose measured ¿20 mg/dl¿ on the ems device before treatment.The patient also mentioned that their healthcare professional stopped their medication until further review.At the time of troubleshooting, the cca noted that an approved sample site was used for testing.The cca noted that the patient was testing with test strips that were expired since 2014.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly received medical intervention for an acute low blood glucose excursion after the alleged inaccuracy issue occurred.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN INC.; 20 valley stream pkwy; malvern PA 19355
• Manufacturer (Section G): LIFESCAN SCOTLAND; beechwood park north; inverness IV2 3 ED; UK IV2 3ED
• Manufacturer Contact: simon palmer ; beechwood park north; inverness IV2 3-ED ; UK IV2 3ED ; 1463383679
• MDR Report Key: 14881557
• MDR Text Key: 295124598
• Report Number: 3009698388-2022-00027
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061118
• 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: 06/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3425531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2022
• 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): Required Intervention; Life Threatening