MAUDE Adverse Event Report: MHC MEDICAL PRODCUTS, LLC. MEMBER'S MARK; TEST STRIPS

Catalog Number 707050

Device Problem Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2018

Event Type  malfunction  

Event Description

Meter reads error 6, which means there is a strip issue.Customer reported that the strips were stored properly and weren't past expiration, but they provided no lot number to verify.

• Brand Name: MEMBER'S MARK
• Type of Device: TEST STRIPS
• Manufacturer (Section D): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODCUTS, LLC.; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240
• MDR Report Key: 7844441
• MDR Text Key: 119498435
• Report Number: 3005798905-2018-00869
• Device Sequence Number: 1
• Product Code: CGA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073492
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 08/08/2018

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: Lay User/Patient
• Device Catalogue Number: 707050
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2018
• Initial Date FDA Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1