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

Lot Number 3177089

Device Problems Shelf Life Exceeded (1567); Low Test Results (2458)

Patient Problems Blurred Vision (2137); Dizziness (2194)

Event Type  Injury  

Manufacturer Narrative

Lifescan (lfs) has requested return of the subject product(s) for evaluation.If the product(s) are returned, lfs will evaluate it/them and inform fda of product(s) that do not pass inspection in a supplemental report.

Event Description

On (b)(6) 2015 the lay user/patient contacted lifescan (lfs) alleging that her onetouch ultra2 meter was reading inaccurately low compared to her feelings and/or usual results.The complaint was classified based on the customer service representative (csr) documentation.The patient could not recall exactly when the alleged inaccuracy began.The patient stated that she obtained results of 45, 30 and 37mg/dl using the subject device, which she felt were low compared to how she was feeling and/or her usual results.The patient manages her diabetes using metformin-500 (2 per day), lisinopril- 20 mg (1 per day) and lantus - 40 units per day, and denied making any changes to her usual diabetes management routine in response to the alleged issue.The patient reported experiencing symptoms of light-headed, dizzy and blurry vision approximately 2 hours after the alleged issue began, and denied receiving any form of medical intervention in response to the reported issue.At the time of troubleshooting, the csr noted that the meter was set with the correct unit of measure, but noted that the test strips being used were passed their expiry date.The csr educated the patient on the correct method of storage.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of severe injury after the alleged meter issue began.

• 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: 5235146
• MDR Text Key: 31567927
• Report Number: 2939301-2015-49745
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• 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: Patient
• Type of Report: Initial
• Report Date: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3177089
• Other Device ID Number: 1-99SMXF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/11/2015
• Device Age: 46 MO
• Date Manufacturer Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2012
• 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): Life Threatening
• Patient Age: 70 YR
• Patient Weight: 80