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

Lot Number 4639325

Device Problem Loss of Power (1475)

Patient Problems Diarrhea (1811); Vomiting (2144); Dizziness (2194)

Event Date 03/03/2021

Event Type  Injury  

Event Description

On (b)(6), 2021, the reporter of the lay user/patient contacted lifescan (lfs) argentina, alleging that the patient¿s onetouch ultra mini meter was powering off during use.This complaint was classified based on information obtained from the customer care agent (cca) during the initial call.The reporter states that the alleged power issue started on (b)(6), 2021 at 9:00 p.M.The reporter claims that the patient started feeling ¿bad¿ on (b)(6), 2021 and obtained blood glucose readings of ¿241, 240, 163 and 238 mg/dl¿ on the subject meter during the day and evening.The following day the patient received readings of ¿243, 262 and 160 mg/dl¿ during day, but was unable to get a reading in the evening due to the alleged issue.The reporter states that the patient usually manages her diabetes with slow acting insulin (type unspecified, 12 units before breakfast, 8 units before a snack and 8 units at 11 p.M.).The reporter also states that after each dose, the patient does not require to measure her blood glucose.However, depending on the result measured before each meal, the patient should apply an amount of fast-acting insulin (type unspecified) as indicated by the doctor as a rescue dose.The reporter claimed that in response to the alleged issue the patient¿s guardian did not administer any medication because she was unable to obtain a result at 9:30 p.M.On (b)(6), 2021.They then hired a private nurse who visited the patient the following morning at 9:15 a.M.And obtained a blood glucose reading of ¿305 mg/dl¿ on the nurse¿s meter.The reporter claims that due to the alleged meter issue the patient has developed symptoms of ¿diarrhea, dizziness, vomiting and all the consequences of having uncontrolled diabetes¿.The reporter states that the patient was treated with fast-acting insulin administered by the nurse.That same day the nurse also obtained readings of ¿238 mg/dl, 166 mg/dl and 134 mg/dl¿ after the patient received treatment.The reporter advised that the readings were decreasing due to the rescue doses administered by the nurse.At the time of troubleshooting, the customer care agent (cca) noted the subject meter was not being used for the first time and that there was no indication of misuse to the device.The cca walked the patient through resolving the alleged power issue and the alleged issue could not be resolved.The cca confirmed that the battery did not need to be replaced.Replacement products were sent to the patient.This complaint is being reported because the reporter claims that the patient was unable to test her blood glucose due to the reported issue and reportedly developed symptoms suggestive of a serious injury adverse event after the alleged meter issue began and the patient reportedly received hcp treatment for an acute high blood glucose excursion.

• Brand Name: OT ULTRA MINI METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11532640
• MDR Text Key: 251240701
• Report Number: 2939301-2021-02842
• 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: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4639325
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention