MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT ULTRA2 METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4353384

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Hypoglycemia (1912); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that his onetouch ultra2 meter displayed inaccurately high results compared to his feelings/normal results.The complaint was classified based on the customer care advocate (cca) documentation.The patient alleged that the meter had been reading inaccurately for 2-3 weeks prior to contacting lfs.He stated that on an unknown date and time, he obtained alleged inaccurately high blood glucose results on the subject meter of ¿200 and 188 or 198 mg/dl¿.(meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy).The patient manages his diabetes with insulin, which he self-adjusts.He reported that after obtaining the alleged inaccurate results, he administered 12 units of novolog and ate breakfast of egg, cheese and coffee.He reported that one and a half hours after obtaining the results, he felt ¿low and shaky¿.He reported that he obtained a result of 56 or 52 mg/dl on his accu-chek meter.No treatment above or beyond the usual routine of diabetes care and management was reported.He indicated that on a recent doctor¿s office visit, the meter was off by 34 mg/dl compared to a laboratory device.During troubleshooting, the patient confirmed that the meter was set to the correct unit of measure and the test strips had been stored correctly and were within expiry date.The patient did not have control solution to test the meter and test strips.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, i.E.Low and shaky, after obtaining alleged inaccurately high results on the meter and administering insulin.

• Brand Name: OT ULTRA2 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7662030
• MDR Text Key: 113154776
• Report Number: 3008382007-2018-01879
• Device Sequence Number: 1
• Product Code: NBW
• UDI-Device Identifier: 00353885008372
• UDI-Public: 00353885008372
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K053529
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/25/2018

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 Lot Number: 4353384
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/25/2018
• Device Age: 12 MO
• Initial Date Manufacturer Received: 06/25/2018
• Initial Date FDA Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2017
• 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