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

Lot Number 4475211

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Shaking/Tremors (2515); Lethargy (2560); Polydipsia (2604)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2019, the lay user/patient contacted lifescan (lfs) usa, alleging that her onetouch ping meter displayed an error message and upon calling the patient back, it was discovered that it was an error 1 message.The complaint was classified based on the customer care advocate (cca) documentation.The patient reportedly obtained the error 1 message on (b)(6) 2019.It was not established how the patient manages her diabetes or whether she made any changes to her usual diabetes management routine as a result of being unable to test.She reported that around 8 hours after obtaining the error message, she developed symptoms of ¿shaky, about to pass out, thirsty and lethargic¿.The patient denied receiving any treatment for her symptoms above or beyond the usual routine of diabetes care and management.The cca arranged to send a replacement meter to the patient.At the time of troubleshooting, the cca noted that the meter was not being used for the first time.The cca asked the patient to remove the battery, hold the power button for 5 seconds and replace the battery but the issue remained unresolved.This complaint is being reported because the patient reportedly developed symptoms suggestive of a serious injury adverse event after obtaining an error 1 message on the subject meter.

• Brand Name: OT PING METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer (Section G): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• Manufacturer Contact: oyinkan donaldson ; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 8690356
• MDR Text Key: 147709155
• Report Number: 3008382007-2019-02088
• Device Sequence Number: 1
• Product Code: CGA
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/05/2019

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: 4475211
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2019
• Device Age: 84 MO
• Initial Date Manufacturer Received: 06/05/2019
• Initial Date FDA Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2012
• 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