MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. MEMBERS MARK; GLUCOSE METER

Catalog Number 707001

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Missing Value Reason (3192)

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Meter giving wrong readings.Bought 2 of them one is opened and the other is not.One reading was reading 400 and 1/2 hour later it read in the 100's.Asked about how many test strips were used and he stated 8-10.He bought 2 meters because one was for his mother and the other for his father in law.Doesn't have the meter with him right now due to him being at work.They are stored in the proper temperature.Sometimes the readings are anywhere from 60-80 to 100-200 he's not 100% sure of his mothers blood sugar but guesses its from 180-200.He went back to sams and they feel it's the meter not the strips.Control solution will also be sent.

• Brand Name: MEMBERS MARK
• Type of Device: GLUCOSE METER
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC.; 11930 kemper springs drive; cincinnnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnnati, OH 45240
• MDR Report Key: 7504408
• MDR Text Key: 107966607
• Report Number: 3005798905-2018-00502
• Device Sequence Number: 1
• Product Code: NBW
• 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: Other
• Type of Report: Initial
• Report Date: 05/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 707001
• Device Lot Number: NOTPROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1