MAUDE Adverse Event Report: MHC MEDICAL PRODUCTS, LLC; SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER

Device Problems False Reading From Device Non-Compliance (1228); Incorrect, Inadequate or Imprecise Result or Readings (1535); Device Operational Issue (2914); Output Problem (3005)

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

Event Date 11/01/2016

Event Type  malfunction  

Event Description

User allegedly had device "strips testing outside of range due to heat exposure.".

• Type of Device: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER
• 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: 7523499
• MDR Text Key: 108569099
• Report Number: 3005798905-2018-00445
• Device Sequence Number: 1
• Product Code: NBW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 05/17/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1