MAUDE Adverse Event Report: AMERICAN DIAGNOSTIC CORPORATION (ADC) ADTEMP II 413; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 413

Device Problems Low Audible Alarm (1016); Difficult or Delayed Activation (2577); Improper Device Output (2953); Packaging Problem (3007)

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

Event Date 07/19/2017

Event Type  malfunction  

Event Description

Issues presented with the thermometers not turning on.If it turns on, a temperature comes up and will not read any further; if it turns on, a questionable calibration of 101-102.1, beep can barely be heard if at all, and poor packaging in plastic sheath with no top closure where product slides out of sheath easily and questionable use since not in packaging.Manufacturer response for thermometer, adtemp ii model 413 (per site reporter).No response as of this time.

• Brand Name: ADTEMP II 413
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): AMERICAN DIAGNOSTIC CORPORATION (ADC); marc blitstein; 55 commerce drive; hauppauge NY 11788
• MDR Report Key: 6735431
• MDR Text Key: 80778131
• Report Number: 6735431
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: 413
• Device Catalogue Number: 413
• Device Lot Number: 17020024
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Event Location: Hospital
• Date Report to Manufacturer: 07/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO