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

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problem No Information (3190)

Event Type  Injury  

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that their onetouch select meter displayed inaccurately high results compared to a laboratory device.The complaint was classified based on customer service representative (csr) documentation.The reporter stated they could not confirm when they first became aware of the meter issue, reporting that they had obtained an alleged inaccurately high blood glucose result on the subject meter compared to a laboratory device.No results or information regarding timings were available.The patient stated that in response to the alleged meter issue, they increased their normal insulin dose.The patient alleged that due to taking an increased dose of insulin, they developed symptoms (unknown), and required to be admitted to hospital for treatment (unknown).During troubleshooting, the csr noted that the patient did not have any test strips.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, after the alleged product issue began.There is insufficient information to rule out the contribution of the subject meter to the event.

• Brand Name: OT SELECT 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: 7662983
• MDR Text Key: 113159334
• Report Number: 3008382007-2018-01905
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• PMA/PMN Number: K072543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 07/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Other Device ID Number: 1-KCTCD7
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/03/2018
• Date Manufacturer Received: 07/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Hospitalization; Life Threatening; Required Intervention