MAUDE Adverse Event Report: LABSTYLE INNOVATIONS LTD. DARIO BLOOD GLUCOSE MONITORING SYSTEM; NBW

Model Number 1021-06

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

Patient Problems Hypoglycemia (1912); Hot Flashes/Flushes (2153); Shaking/Tremors (2515)

Event Date 02/23/2022

Event Type  malfunction  

Event Description

On february 23rd, 2022, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported that on the evening of february 3rd, before he was about to eat, he started sweating and shaking.The user tested his bg level which read 179 mg/dl on the dario meter.Due to the above, the user went to the er where his bg was tested and read in the upper 50 mg/dl range with the hospital's meter.At the hospital, in order to help raise his bg level, the user received a glucose tablet, after which the user's bg level was tested again and he received a reading of 113 mg/dl with the hospital's meter.A replacement of dario's strips and control solution were sent to the user to further investigate this issue.After the above was received, dario's representative followed up with the user and did a control solution test with the new cartridge of strips.The strips were reading within range.While on the phone with dario's representative, the user reported that 4 months prior to this incident, his physician discontinued all of his medications.On march 14th, 2022, the user contacted dario once again to report inconsistent blood glucose (bg) readings when testing several times in a row, and when comparing his dario meter to his non-dario meter.The customer reported a 20 mg/dl to 40 mg/dl difference between the two meters.A replacement of dario's meter, was sent to the user together with a return material authorization (rma) package, to further investigate this issue.As of this date, the rma with the old dario meter was not received.If the rma is received at a later date, a follow up report will be submitted.There is not enough information regarding the old strips and meter to investigate.No resolution is available.

Event Description

On (b)(6) 2022, the user contacted dario to report inconsistent blood glucose (bg) readings.The user reported that on the evening of february 3rd, before he was about to eat, he started sweating and shaking.The user tested his bg level which read 179 mg/dl on the dario meter.Due to the above, the user went to the er where his bg was tested and read in the upper 50 mg/dl range with the hospital's meter.At the hospital, in order to help raise his bg level, the user received a glucose tablet, after which the user's bg level was tested again and he received a reading of 113 mg/dl with the hospital's meter.A replacement of dario's strips and control solution were sent to the user to further investigate this issue.After the above was received, dario's representative followed up with the user and did a control solution test with the new cartridge of strips.The strips were reading within range.While on the phone with dario's representative, the user reported that 4 months prior to this incident, his physician discontinued all of his medications.On (b)(6) , 2022, the user contacted dario once again to report inconsistent blood glucose (bg) readings when testing several times in a row, and when comparing his dario meter to his non-dario meter.The customer reported a 20 mg/dl to 40 mg/dl difference between the two meters.A replacement of dario's meter, was sent to the user together with a return material authorization (rma) package, to further investigate this issue.As of this date, the rma with the old dario meter was not received.If the rma is received at a later date, a follow up report will be submitted.There is not enough information regarding the old strips and meter to investigate.No resolution is available.Addition for the follow-up report: the rma package was received for investigation on march 30th, 2022.The meter was tested, and was reading within range.Therefore, it was determined that this complaint is not due to a meter issue.There is not enough information regarding the dario strips to investigate.No resolution is available.

• Brand Name: DARIO BLOOD GLUCOSE MONITORING SYSTEM
• Type of Device: NBW
• Manufacturer (Section D): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer (Section G): LABSTYLE INNOVATIONS LTD.; 8 hatokhen st.; north industrial park; caesarea, 30889 00; IS 3088900
• Manufacturer Contact: rick anderson ; 18 w. 18th street; 5th floor; new york, NY 10011 ; 3106251600
• MDR Report Key: 13859620
• MDR Text Key: 287671336
• Report Number: 3010606081-2022-00007
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K150817
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1021-06
• Device Lot Number: 2108031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male