MAUDE Adverse Event Report: LIFESCAN EUROPE GMBH OT SELECT SIMPLE METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4486456

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

On (b)(6) 2019, the reporter contacted lifescan (b)(4), alleging that the subject meter read inaccurately [high/low] compared to a laboratory device.The reporter claimed obtaining blood glucose readings of ¿10.0 mmol/l¿ with the subject meter and ¿5.0 mmol/l¿ on the laboratory device.The tests were performed within 10 minutes of each other.Based on statistical methodology, the calculated difference of these glucose results exceeds lifescan¿s criteria for accuracy.This complaint is being reported because the reported issue was not resolved with troubleshooting.There was no indication that the product caused or contributed to an adverse event.

• Brand Name: OT SELECT SIMPLE METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8548213
• MDR Text Key: 143438779
• Report Number: 3008382007-2019-01275
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial
• Report Date: 04/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4486456
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2019
• Date Manufacturer Received: 04/15/2019
• 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