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

Device Problems Shelf Life Exceeded (1567); High Test Results (2457)

Patient Problem No Code Available (3191)

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 patient contacted lifescan (lfs) alleging that his onetouch ultra fasttake meter was reading inaccurately high compared to another meter.The complaint was classified based on the customer care advocate (cca) documentation.The patient alleged that the inaccuracy began ¿a few weeks ago¿.The patient detailed that he was unable to recall the alleged high reading he obtained on the subject meter which he compared to the reading of ¿30 ¿ 35¿mg/dl obtained on another meter (freestyle lite) performed within 30 minutes of each other.The patient manages his diabetes with insulin (self-adjuster) and reported taking more food and/or drink as a result of the alleged product issue.The patient stated that on an unspecified date and time after the alleged issue began, he ¿had trouble waking up and called emergency medical team (emt)¿.The patient reported that whilst in emergency room (er) he was treated by a health care professional (hcp) with ¿iv glucose¿.He also stated that he performed a blood glucose result on the emt meter.However could not recall the result.At the time of troubleshooting, the cca confirmed the subject meter was set to the correct unit of measure and an approved sample site was used to obtain the result.However, the incorrect testing steps were carried out, the test strips had expired.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly suffered symptoms suggestive of a serious injury after the alleged product issue began.

• Brand Name: OT FASTTAKE 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: m. chiusano / y. wandolski ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 5213028
• MDR Text Key: 30837455
• Report Number: 2939301-2015-48110
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011479
• 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: 11/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-AV-1017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/04/2015
• Device Age: 209 MO
• Date Manufacturer Received: 11/04/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/28/1998
• 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