MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC EASY TOUCH; GLUCOSE TEST STRIPS

Model Number N/A

Device Problem High Test Results (2457)

Patient Problem No Information (3190)

Event Date 09/07/2017

Event Type  Injury  

Event Description

End user's test strips not testing properly.End user visited the emergency room as a result.Test strips testing very high(200-300mg/dl).

• Brand Name: EASY TOUCH
• Type of Device: GLUCOSE TEST STRIPS
• Manufacturer (Section D): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer (Section G): MHC MEDICAL PRODUCTS, LLC; 11930 kemper springs drive; cincinnati OH 45240
• Manufacturer Contact: jennifer seiple ; 11930 kemper springs drive; cincinnati, OH 45240 ; 8773584342
• MDR Report Key: 7366512
• MDR Text Key: 103338559
• Report Number: 3005798905-2018-00042
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 02/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2019
• Device Model Number: N/A
• Device Catalogue Number: 807050
• Device Lot Number: 460105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2017
• 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
• Patient Outcome(s): Hospitalization