MAUDE Adverse Event Report: ROCHE ACCU CHEK GLUCOSE TEST STRIPS

Model Number 397 CODE TEST STRIPS

Device Problems Device Expiration Issue (1216); Packaging Problem (3007)

Patient Problem Hypoglycemia (1912)

Event Date 05/14/2014

Event Type  Other  

Event Description

Roche accu chek glucose meter disables ability to use expired test strips without advance notice or advisory on test strip or meter packaging.This came as a big surprise yesterday when i needed to test for very low blood sugar based on symptoms and strips with expiration date of april 30, 2014 failed to operate in the meter.I contacted the company and they told me the strips are not good after the expiration.There is a difference between "good" and "usable".If they wish to disable the strips on the expiration date, this is important user info that should be displayed on the strip and meter packaging - at the very least, included with instructions.Disabling a device on expiration is not a standard medical industry practice.It is something associated with software sales that would not affect human health.The company is now pursuing me with phone calls and emails and wants to retrieve my old meter and test strips.I cannot return my meter because it contains my blood testing history.Can you help me with this.

• Brand Name: ACCU CHEK GLUCOSE TEST STRIPS
• Type of Device: TEST STRIPS
• Manufacturer (Section D): ROCHE
• MDR Report Key: 3826781
• MDR Text Key: 4504819
• Report Number: MW5036178
• 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: Other
• Type of Report: Initial
• Report Date: 05/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2014
• Device Model Number: 397 CODE TEST STRIPS
• Device Catalogue Number: 05987458001
• Device Lot Number: 491397
• Other Device ID Number: 1CV0700611 13970030
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR
• Patient Weight: 95