MAUDE Adverse Event Report: LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL OT PING METER; GLUCOSE MONITORING SYS/KIT

Lot Number 4337177

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Dizziness (2194); Malaise (2359); Sweating (2444)

Event Date 06/19/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ping meter displayed inaccurately high results compared to her feelings/normal results.The complaint was classified based on the customer care advocate (cca) documentation.It is unclear when the alleged inaccuracy issue started.The patient reported that in the past, she had obtained alleged inaccurately high blood glucose results on the subject meter of ¿316, 318, 320 and 376 mg/dl¿, and at 9:30am on (b)(6) 2018, another alleged inaccurate result of ¿413 mg/dl¿.(meter to feelings/normal results comparisons do not meet the criteria necessary for lfs to determine an inaccuracy).The patient manages her diabetes with insulin pump therapy.She reported that after obtaining the alleged inaccurate result of 413 mg/dl, she had administered an unspecified quantity of insulin.She reported that 2 hours later, she developed symptoms of ¿dizziness, didn¿t feel good and transpiring profusely¿ which she associated with low blood sugar.She indicated that she took a teaspoon of honey to treat her symptoms at around 12pm on (b)(6) 2018.During troubleshooting, the patient confirmed that the meter was set to the correct unit of measure and her test strips had been stored correctly and were within expiry date.The patient did not have control solution to test the meter and test strips.Replacement products, including control solution, were sent to the patient.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event, i.E.Dizziness, transpiring profusely and not feeling well, after obtaining an alleged inaccurately high result on the meter and administering insulin.

• Brand Name: OT PING METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: mariano chiusano ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 7644688
• MDR Text Key: 112547839
• Report Number: 3008382007-2018-01825
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K082590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4337177
• Other Device ID Number: 1-NQGOP7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/19/2018
• Device Age: 47 MO
• Date Manufacturer Received: 06/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/15/2014
• 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; Required Intervention
• Patient Age: 81 YR