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

Lot Number 4299731

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

Patient Problems Fainting (1847); Cramp(s) (2193); Dizziness (2194)

Event Date 02/08/2019

Event Type  Injury  

Event Description

On (b)(6) 2019, a reporter for the patient contacted lifescan (b)(4), alleging that the patient¿s onetouch select simple meter read inaccurately high in comparison to her feelings/normal results.The complaint was classified based on customer service representative (csr) documentation and a review of the call by a senior csr.The reporter advised the csr that on (b)(6) 2019, the patient obtained an alleged inaccurately high reading of ¿302 mg/dl¿ on the subject meter, which she compared to her feelings/normal results.Meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy.The reporter stated that the patient manages her diabetes with self-adjusted insulin doses (unspecified type or dosage).The reporter did not specify if the patient made any changes to her usual routine of diabetes management in response to the alleged inaccurately high reading.He explained that on (b)(6) 2019, the patient experienced ¿dizziness and cramps in her legs, and then fainted¿ and that the patient was then taken to hospital.He stated that a blood glucose test was performed on the patient and obtained a result of ¿50 mg/dl¿, and that she was treated by a healthcare professional with intravenous glucose.At the time of troubleshooting, the csr confirmed that the correct unit of measure was used and that the patient¿s test strips had been stored correctly, were within expiry date.The csr walked the patient through a control solution test which did not fall within the specified range (126-171 mg/dl) on the test strip vial.Replacement products were sent to the patient.This complaint is being reported because the patient reportedly developed signs and symptoms suggestive of a serious injury adverse event after obtaining alleged inaccurate high results with the subject meter.

Manufacturer Narrative

The lay user/patient's 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.In addition, a device history record review was performed on the subject meter lot.The review did not identify anything that could adversely impact product performance or function.Lifescan also conducted an evaluation of the test strip lot and concluded that this lot did not breach the thresholds set for escalation and no systemic issue was observed.Analysis was not possible for the returned test strips due to unknown storage and handling preventing the allegation being physically investigated, however a secondary issue was noted; the shelf-life had exceeded.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: 8385356
• MDR Text Key: 137671442
• Report Number: 3008382007-2019-00594
• Device Sequence Number: 1
• Product Code: NBW
• 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: 02/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4299731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/16/2019
• Device Age: 19 MO
• Date Manufacturer Received: 02/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention