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

Model Number 021-098

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

Patient Problems Fatigue (1849); Diaphoresis (2452); Increased Appetite (4570)

Event Date 10/05/2020

Event Type  Injury  

Event Description

On (b)(6) 2020, the patient contacted lifescan (lfs) us, alleging that their onetouch ultra 2 meter was reading inaccurately high.This complaint was classified based on the customer care agent (cca) documentation.The patient reported that the alleged inaccuracy issue began at 01:00 on (b)(6) 2020.The patient claimed obtaining results of "556 mg/dl" (01:00, (b)(6) 2020), "181 m/dl" (02:04, (b)(6) 2020), "261 mg/dl" (08:43, 05 october 2020) and "204 mg/dl" (13:14, (b)(6) 2020) on the subject device.The patient manages their diabetes with oral medication ("glucozan, 5 mg", and "jardiance, 10 mg").The patient reported that she took "jardiance, 25 mg and, glucozan, 5 mg after each test taken" and that she stopped eating in response to the alleged elevated readings obtained on the subject device.The patient reported that at 02:00 on (b)(6) 2020, she became "weak", started to "sweat" and that she was "starving".The patient advised that she went to the hospital at 13:15 on (b)(6) 2020, where her blood glucose was reportedly tested at "55, 56 and 58 mg/dl" on the hospital device.The patient advised the cca that she was subsequently treated with orange juice and peanut butter crackers until her blood glucose reached "at least 90 mg/dl" during troubleshooting, the cca established that the unit of measure was set correctly on the subject device at the time of testing.The cca noted that the patient did not have control solution to perform a control solution 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 and required treatment for an acute low blood glucose excursion from a health care professional after administering medication based on the alleged inaccurately high blood glucose readings obtained on the subject device.

• 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: 10780008
• MDR Text Key: 214403091
• Report Number: 2939301-2020-02749
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885000277
• UDI-Public: 00353885000277
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 021-098
• Device Catalogue Number: 021-098
• Device Lot Number: 4613180
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 10/06/2020
• 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