MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT ULTRA 2 METER; GLUCOSE MONITORING SYS/KIT

Model Number 021-105

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

Patient Problems Fatigue (1849); Dizziness (2194); Confusion/ Disorientation (2553); Presyncope (4410); Increased Appetite (4570)

Event Date 10/31/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the lay-user/patient contacted lifescan (lfs) usa, alleging that her onetouch ultra2 meter read inaccurately erratic and inaccurate compared to her feelings and/or normal readings.The complaint was classified based on the customer care agent (cca) documentation and on additional information obtained by the medical surveillance specialist after reviewing the call recording.The patient reported that towards the end of (b)(6) 2020, she began to obtain inaccurate readings always in the morning between 5:30 am to 7:00 am.The patient reported obtaining blood glucose readings of ¿137, 239, 137 and 137 mg/dl¿ with the subject meter, performed more than 20 minutes apart.The patient also reported obtaining what she felt were inaccurate results of ¿239, 137, 143, 215, 174, 126, 139, 120, 91, 137, 116, 110 and 137 mg/dl¿ with the subject meter.The patient stated that she manages her diabetes with oral medication (glimepiride 2 mg) and denied making any changes to her usual diabetes management regimen as a result of the alleged issue.During the call, the patient reported that up until the week prior to contacting lfs, she experienced intermittent episodes between 10:30 am to 11:30 am of feeling ¿faint, feeling like passing out, feeling like she needed something to eat, weak and out of it.¿ the patient reported testing her blood glucose with the subject meter at the onset of symptoms and obtaining a ¿low¿ result (exact reading not provided).In response to the symptoms, the patient claimed she treated herself with food and drink and the symptoms resolved.At the time of troubleshooting, the cca confirmed the unit of measure was set correctly on the subject meter.The cca documented that the same approved sample site was used for testing and that the correct testing process was being followed.The cca noted the patient did not have control solution available to perform a quality control test.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs/symptoms suggestive of a serious injury adverse event after the alleged product issue began.The subject meter could not be ruled out as a cause or contributor to the event.

Manufacturer Narrative

The lay user/patient¿s meter has been returned and evaluated by lifescan product analysis with the following findings: the meter passed performance testing with no faults found.The reported issue could not be confirmed.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.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.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• Brand Name: OT ULTRA 2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 11062570
• MDR Text Key: 223386310
• Report Number: 3008382007-2020-04083
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 12/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-105
• Device Catalogue Number: 021-105
• Device Lot Number: 4553053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2021
• Initial Date Manufacturer Received: 12/04/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 04/12/2021
• Supplement Dates FDA Received: 04/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening