MAUDE Adverse Event Report: SHENZEN PACOM MEDICAL INSTRUMENTS CO., LTD. FLTR INFRARED THERMOMETER #TMP102/PC828; THERMOMETER, ELECTRONIC, CLINICAL

Model Number TMP102/PC828

Device Problem High Readings (2459)

Patient Problem Anxiety (2328)

Event Date 12/06/2020

Event Type  malfunction  

Event Description

Incorrect temperature reading; fltr tmp102/pc828 infrared thermometer over a 6 week period gave continual inconsistent and incorrect temperature readings which resulted in unnecessary treatment for fever.Early(b)(6) 2020 i had non-covid flu symptoms -- nausea, g.I.Distress anorexia, etc., and elevated and inconsistent temperature readings on the fltr device.Within 3 weeks all symptoms were gone but the fevers.I was referred to an i.D.Specialist for evaluations, subjected to multiple exams and tests and all negative but indication that i had a virus, but the fever, as shown by the fltr thermometer, continued and the readings continue to this day.I was scheduled for invasive g.I testing when my primary care md suggested i take my temp with a mercury thermometer, both rectal and oral and did so within minutes of the fltr reading, which i have done numerous times in the past three weeks.My mercury thermometer readings were consistently normal and below while the fltr read between 98.8 and 100.7.These readings caused much anxiety, referral to an i.D.Specialist and much unnecessary treatment and testing.Fda safety report id# (b)(4).

• Brand Name: FLTR INFRARED THERMOMETER #TMP102/PC828
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SHENZEN PACOM MEDICAL INSTRUMENTS CO., LTD.
• MDR Report Key: 11286088
• MDR Text Key: 230754970
• Report Number: MW5099251
• Device Sequence Number: 1
• Product Code: FLL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: TMP102/PC828
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 84 YR
• Patient Weight: 54