MAUDE Adverse Event Report: WAL-MART STORES, INC. RELION PRIME GLUCOSE TEST STRIPS; GLUCOSE OXIDASE, GLUCOSE

Model Number NDC 08317-7000-50

Device Problems Expiration Date Error (2528); Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

Purchased bottle of 50 relion prime blood glucose test strips at (b)(6).On the outer box: lot: 060820d, exp: 2022-02-10.On the bottle: lot 100918a, exp: 2020-05-08.Are they 3 months past expiration? fda safety report id# (b)(4).

• Brand Name: RELION PRIME GLUCOSE TEST STRIPS
• Type of Device: GLUCOSE OXIDASE, GLUCOSE
• Manufacturer (Section D): WAL-MART STORES, INC. ; 702 sw 8th st; bentonville AR 72716
• MDR Report Key: 10419674
• MDR Text Key: 203490643
• Report Number: MW5096097
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/10/2022
• Device Model Number: NDC 08317-7000-50
• Device Catalogue Number: UPC 605388022943
• Device Lot Number: 060820D
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 73 YR