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

Lot Number 4433630

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

Patient Problems Chills (2191); Dysphasia (2195); Sweating (2444)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) (b)(4), alleging that her onetouch select simple meter read inaccurately high compared to her feelings and/or normal readings.The complaint was classified based on the customer service representative (csr) documentation.The patient reported that the alleged meter inaccuracy began on (b)(6) 2018 at 3:30 pm.The patient reported obtaining an alleged inaccurate high blood glucose reading of ¿152 mg/dl¿ with the subject meter.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The patient reported that at the same time as obtaining the alleged inaccurate reading she developed symptoms of feeling "uneasy and sweating".The patient reported that she manages her diabetes with oral medication in combination with diet and exercise and denied making any change to her usual diabetes management routine in response to the alleged high reading.The patient reported that the symptoms continued and after sometime she developed additional symptoms of being "unable to speak and shivering".The patient claimed that at approximately 3:45 pm she was hospitalized and had her blood glucose taken on the hospitals meter and a result of "35 mg/dl" was obtained.The patient reported receiving iv glucose as treatment in the hospital and was discharged on the same day by 9 pm.During troubleshooting, the csr noted that the unit of measure was set correctly on the subject meter.In addition, the csr confirmed that the patient¿s test strips had been stored correctly and were within their expiry/discard date.The patient did not have control solution to perform a quality control test.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 and required medical intervention after she obtained an alleged inaccurate high result with the subject meter.

Manufacturer Narrative

The lay user/patients meter and test strips have been returned and evaluated by lifescan product analysis with the following findings: the meter passed all testing with no faults found.The reported issue could not be confirmed.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated.If lifescan obtains additional information regarding this complaint, a follow-up report will be submitted.At this time, lifescan considers this matter closed.

• 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
• MDR Report Key: 8105018
• MDR Text Key: 128414170
• Report Number: 3008382007-2018-03264
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Type of Report: Initial,Followup
• Report Date: 11/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4433630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/10/2018
• Date Manufacturer Received: 11/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention