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

Lot Number 4241889

Device Problem Incorrect Or Inadequate Test Results (2456)

Patient Problems Sweating (2444); Shaking/Tremors (2515)

Event Date 04/21/2018

Event Type  Injury  

Event Description

On (b)(6) 2018, a reporter for the patient (the patient¿s mother) contacted lifescan (lfs) usa, alleging that the patient¿s onetouch ping meter displayed inaccurately erratic results.The complaint was classified based on the customer care advocate (cca) documentation.The reporter claimed that the subject meter was reading inaccurately at 12:55 pm on (b)(6) 2018, when the patient obtained alleged inaccurately erratic blood glucose results of ¿22 and 254 mg/dl¿, performed within 20 minutes of each other.Based on statistical methodology, the calculated difference between the reported results falls outside lfs¿ precision criteria.The patient manages his diabetes with insulin.The reporter indicated that prior to obtaining the alleged inaccurate results, the patient developed symptoms of ¿sweatiness and shakiness¿.She denied that the patient required any treatment for his symptoms above and beyond the usual routine of diabetes care and management.At the time of troubleshooting, the cca confirmed that the meter was set to the correct unit of measure.The reporter indicated that the patient had used an approved sample site to obtain the blood samples.She confirmed that the patient¿s test strips were within expiry date and had been stored correctly in an intact vial and she described the correct testing steps.The reporter did not have control solution to test the meter and test strips.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, i.E.Sweatiness and shakiness while using the meter.

• 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: 7463571
• MDR Text Key: 106585786
• Report Number: 3008382007-2018-01271
• Device Sequence Number: 1
• Product Code: LZG
• Combination Product (y/n): N
• 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: 04/21/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4241889
• 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: 04/21/2018
• Device Age: 6 MO
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2017
• 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