MAUDE Adverse Event Report: AMERICAN DIAGNOSTIC CORPORATION ADTEMP 413 DIGITAL THERMOMETER

Model Number 413B

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/19/2017

Event Type  malfunction  

Manufacturer Narrative

After receiving initial email report, a complaint file was opened and existing stock of the same model was evaluated.It was determined that the thermometer stock was functioning properly in regards to powering on, reading, and providing audible beeps.In relation to the 101-102.1 on screen display reported by the user facility, it was determined that the end users were not viewing a calibration display but rather a last reading memory stored from calibration testing done prior to distribution of this thermometer.These thermometers are given 100% accuracy testing on calibrated water baths with the final test point being approximately 101' f.Finally, these products are provided with scabards designed to shield the probe in storage.The scabards are not packaging and are designed to be easily removed.They were found to be working as intended on existing stock.The actual thermometers involved in the complaint were returned on 7/28/2017 and were tested at our facility using a water bath calibrated to nist traceable standards.The user facility returned used products as well as stock still in its original packaging and unopened.The eight used thermometers had been used until they had low batteries, and the unopened product was sampled for functionality as well.All thermometers tested within +/- 0.1' c during this accuracy testing and were found to be working as intended with no device malfunction.

Event Description

Received emailed complaint on 7/19/2017 through our sales rep and then a follow-up medwatch form on 7/26/2017.Emailed complaint stated that end user facility was having an issue with the model 413 digital stick thermometers.Stated issues included: thermometer won't turn on.Once on, calibration set too high at 101-102.1 not that 98.6 that has been seen in the past.If it turns on, temperature comes up and will not read past that.Audible beep can barely be heard or not at all.Poorly packaged-falling out of packaging very easily.This packaging is a plastic sheath with no closure at top.No patients were involved with the problems indicated above.

• Brand Name: ADTEMP 413 DIGITAL THERMOMETER
• Type of Device: THERMOMETER
• Manufacturer (Section D): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• Manufacturer (Section G): AMERICAN DIAGNOSTIC CORPORATION; 55 commerce drive; hauppauge NY 11788
• Manufacturer Contact: michael falco ; 55 commerce drive; hauppauge, NY 11788 ; 6312739600
• MDR Report Key: 6756335
• MDR Text Key: 81726514
• Report Number: 2434008-2017-00003
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00634782053598
• UDI-Public: 00634782053598
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K940686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/19/2017,07/31/2017

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: Nurse
• Device Model Number: 413B
• Device Catalogue Number: 413B
• Device Lot Number: NOT LOT CONTROLLED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/19/2017
• Distributor Facility Aware Date: 07/19/2017
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/26/2017
• Initial Date Manufacturer Received: 07/26/2017
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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