MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC. EASYTOUCH; BLOOD GLUCOSE MONITORING SYSTEM

Catalog Number 807002

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460)

Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)

Event Date 10/05/2018

Event Type  malfunction  

Event Description

Meter produces er1 and lo reading.

• Brand Name: EASYTOUCH
• Type of Device: BLOOD GLUCOSE MONITORING SYSTEM
• 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
• MDR Report Key: 8035796
• MDR Text Key: 126060988
• Report Number: 3005798905-2018-02730
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 11/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 807002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Date Manufacturer Received: 10/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1