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

Lot Number 4247028

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

Patient Problems Endophthalmitis (1835); Weakness (2145); Sweating (2444)

Event Type  Injury  

Event Description

On (b)(6) 2019, the lay user/ patient contacted lifescan (lfs) (b)(4) alleging that her daughter¿s onetouch select meter was reading inaccurately high compared to another (onetouch select) meter.The complaint was classified based on customer service representative (csr) documentation.The reporter stated that her daughter¿s onetouch select meter began to read inaccurately at an unknown time on (b)(6) 2019, when she obtained the alleged inaccurately high result of ¿9-10 mmol/l¿ compared to a result of ¿around 5 mmol/l¿ obtained with another, onetouch select, meter within 30 minutes.Meter to other meter comparisons do not reasonably suggest that a malfunction has occurred.There can be no presumption as to which meter¿s reading is erroneous as the comparison is not made to a calibrated reference method.The patient manages her diabetes with insulin pump therapy and the reporter claimed that, in response to the alleged inaccurately high result obtained, her daughter took an increased dose of insulin.The reporter claimed that, at an unknown time after the product issue, her daughter began to develop the symptoms of ¿weakness, sweat and circles under the eyes¿.The reporter did not state if the patient received any treatment for her alleged symptoms.During troubleshooting, the csr verified that the test strips had been stored correctly and had not expired, the test strip vial was not cracked or broken, the subject meter¿s unit of measure was set correctly at the time of testing, the patient¿s testing process was correct, and the results obtained were from an approved sample site.The csr was unable to walk the reporter or patient through a control solution test as they did not have any control solution.Replacement products were sent to the patient and reporter.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 an alleged inaccurately high result obtained 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.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 METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8273126
• MDR Text Key: 133977324
• Report Number: 3008382007-2019-00274
• 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,Followup
• Report Date: 01/21/2019

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: 4247028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/21/2019
• Initial Date Manufacturer Received: 01/21/2019
• Initial Date FDA Received: 01/24/2019
• Supplement Dates Manufacturer Received: 01/21/2019
• Supplement Dates FDA Received: 03/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening