MAUDE Adverse Event Report: PRODIGY DIABETES CARE, LLC PRODIGY POCKET GLUCOMETER AND TEST STRIPS; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problem False Reading From Device Non-Compliance (1228)

Patient Problem Loss of consciousness (2418)

Event Date 06/21/2018

Event Type  Injury  

Event Description

Prodigy glucometer gave false readings, which resulted in over medication and loss of consciousness.Ambulance and overnight care were required.If pt had been alone, could well have resulted in death.Company seemed more interested in finding a way to blame some other medical factor.At time ambulance arrived, prodigy meter read 72 ml.Emt recorded 28 on their device.Subsequent calibration test reports meter functioning properly.Company did not appear to be doing anything to protect others who may be at risk.

• Brand Name: PRODIGY POCKET GLUCOMETER AND TEST STRIPS
• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• Manufacturer (Section D): PRODIGY DIABETES CARE, LLC
• MDR Report Key: 7637862
• MDR Text Key: 112468569
• Report Number: MW5078056
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention; Disability
• Patient Age: 68 YR
• Patient Weight: 104