MAUDE Adverse Event Report: GE GE100

Lot Number Y555KKC0489

Device Problems Inadequate Storage (1600); High Test Results (2457)

Patient Problem Hypoglycemia (1912)

Event Type  malfunction  

Event Description

Pt came to me because he was receiving error messages most of the time when he was trying to test his blood sugar using a ge meter he received through the dispensary of hope program.He checked it in front of me and got a reading, which was 575.I asked him if his blood sugar was normally that high.He said yes, but he just came from the doctor's office, where it was 228.I told him i thought the meter might be defective, so i opened a new meter of the same brand and asked him to retest.When he did, it was 476.I asked him to go the md office, where they retested and got a reading of 199.When he came back to see me we ran a new one touch ultra 2 meter through his insurance and i asked him if i could investigate the cause of the readings and get back with him.Upon further investigation, i realized that the meter likely hadn't been checked using the control solution.Of note i checked our dispensary of hope logs and is stated that on (b)(6) 2016 he received the meter.Strips, lancets, and the control solution.I asked him to bring the new meter back to me as well, so we can make sure it is set up properly together.I looked at the user guide for his new meter and confirmed it also uses the control solution so informed him of that over the phone.He stated that he had been giving himself insulin based on the readings from the ge meter and had been hospitalized several times due to hypoglycemia.When we checked with the control solution, both the meters we used were out of range.I called ge, who gave me a certificate of analysis for the strips and told me they felt it was likely due to improper storage of the strips.

• Brand Name: GE100
• Type of Device: GE100
• Manufacturer (Section D): GE
• MDR Report Key: 5612090
• MDR Text Key: 43898937
• Report Number: MW5061892
• Device Sequence Number: 1
• Product Code: CGA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 04/22/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: Y555KKC0489
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1