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

Lot Number 4646984

Device Problem Insufficient Information (3190)

Patient Problems Fall (1848); Convulsion/Seizure (4406)

Event Date 09/01/2021

Event Type  Injury  

Event Description

On (b)(6) 2021, the lay user/patient contacted lifescan (lfs) usa, alleging that his unspecified onetouch meter read inaccurately high compared to his normal readings.The complaint was classified based on the customer care agent (cca) documentation.A follow-up attempt was made by customer care (cc) to obtain additional information; however, the patient was unavailable for answering questions.The patient reported that the alleged meter inaccuracy started approximately a month prior to the call with lfs at an unspecified time.The patient claimed that since that time he obtained alleged inaccurate high blood glucose readings of ¿368, 400, 460, 380 and 499 mg/dl¿ with the subject meter.The patient manages his diabetes with insulin (type and dose unspecified) and he stated that he took more (unspecified amount) insulin and overdosed in response to the alleged issue.At an unspecified time after the alleged issue occurred, the patient developed ¿convulsions¿ and as a result ¿fell off the stairs¿.The patient informed the agent that his wife called 911 and he was taken to the hospital where he was kept under observation.The patient did not specify if and what treatment he received at the emergency room (er) for the reported symptoms, however, he stated that during the day in the hospital several blood glucose readings were obtained varying between ¿100 and 116 mg/dl¿ on an unspecified meter.The patient claimed that he had to reduce his insulin intake after he came back from the er.At the time of the call, the cca established that the subject test strip vials had been first opened approximately 1 month ago and had been stored away from humidity.Replacement test strips and 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 after taking an increased dose of insulin based on alleged inaccurate high results obtained with the subject meter.The subject meter could not be ruled out as a cause or contributor to the event.

• Brand Name: UNKNOWN METER
• Type of Device: GLUCOSE MONITORING SYS/KIT
• Manufacturer (Section D): LIFESCAN EUROPE GMBH; gubelstrasse 34; zug 6300 ; SZ 6300
• MDR Report Key: 12716179
• MDR Text Key: 281197193
• Report Number: 3008382007-2021-04257
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Lot Number: 4646984
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening