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

Lot Number 3902343

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

Patient Problems Sweating (2444); Shaking/Tremors (2515)

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) (b)(4) alleging that his onetouch verioiq meter was reading inaccurately high compared to another meter.The complaint was classified based on the customer service representative (csr) documentation.The patient was unable to remember exactly when the alleged issue began, but stated that it was approximately one week ago when he allegedly obtained a blood glucose result using the subject device that was approximately 100mg/dl higher than a measurement taken using his mother's meter (brand unknown, and actual results not available), both readings within 30 minutes of each other.The patient stated that he does not take any medications to manage his diabetes, and reportedly increased his food and/or drink consumption in response to the reported issue.The patient reported experiencing symptoms of sweat, white and shakiness although it is unclear whether these symptoms were before or after the alleged issue began.The patient stated that he self-treated by consuming a sugary drink in response to the reported issue.The patient confirmed that his blood glucose had not been measured using any other device.At the time of troubleshooting, the csr noted that the meter was set with the correct unit of measure, an approved sample site was used and the patient's testing procedure was correct.The csr also 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.Although the patient was unable to state whether the symptoms were experienced before or after the alleged product issue began, this complaint is being reported for the following reason: it cannot be said with absolute certainty that the alleged "inaccurate" subject meter results did not affect treatment options prior to the onset of these symptoms.

• Brand Name: OT VERIO IQ 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: 5352940
• MDR Text Key: 35317513
• Report Number: 2939301-2016-00943
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• PMA/PMN Number: K110637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 3902343
• Other Device ID Number: 1-1960Z86
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/30/2015
• Device Age: 33 MO
• Date Manufacturer Received: 12/30/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2013
• 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; Required Intervention