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

Lot Number 4413261

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

Patient Problems Syncope (1610); Hypoesthesia (2352)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/ patient contacted lifescan (lfs) (b)(4) alleging that her mother¿s onetouch select meter was reading inaccurately erratic.The complaint was classified based on customer service representative (csr) documentation.The reporter claimed that the alleged product issue first started at an unspecified date and time when her mother obtained the alleged inaccurately erratic results of ¿a little more than 10.0 mmol/l¿ and ¿28.0 mmol/l¿ within 20 minutes of each other.The tests were performed with test strips from two different vials.Comparisons using different vials of test strips do not reasonably suggest that a malfunction has occurred.The patient manages her diabetes with insulin ¿ self adjuster and the reporter claimed that, in response to the alleged product issue, the patient took the appropriate dose of insulin for the result of ¿28.0 mmol/l¿, based on a sliding scale.The reporter stated that the patient then began to develop the symptoms of ¿pre-coma and numbness in hands and legs¿.It is unclear from the documentation provided whether the patient received any treatment in response to these alleged symptoms.During troubleshooting, the csr verified that the subject meter¿s unit of measure was set correctly at the time of testing, the results were obtained from the same approved sample site, the patient¿s testing process was correct, the test strips had been stored correctly and had not expired and the test strip vial was not cracked or broken.The csr was unable to walk the patient or reporter through a control solution test as they did not have any control solution.Replacement products were not sent to the patient or reporter as the patient was not present at the time of the initial call and the reporter wanted to confirm with the patient if she wanted to receive replacement products.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after taking an increased dose of insulin due to alleged inaccurately erratic results obtained with the subject meter.

• Brand Name: OT SELECT 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: 8324452
• MDR Text Key: 135677995
• Report Number: 3008382007-2019-00404
• 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: 02/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4413261
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/01/2019
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/09/2019
• 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
• Patient Outcome(s): Life Threatening