MAUDE Adverse Event Report: SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD. FLTR; INFRARED THERMOMETER

Model Number PC828

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Anxiety (2328)

Event Date 12/06/2020

Event Type  malfunction  

Event Description

We received a notification letter of patient complaint and forwarded by mdr team of fda on feb.25, 2021.The report number is mw5099251, we saw that the patient (b)(6)declared she got much anxiety and did much unnecessary treatment and testing during using our product- infrared thermometer pc828.As her description, when she just recovered from a non-covid flu symptoms, pc828 still continual gave her inconsistent and incorrect temperature readings about 3 weeks, caused her had to consult primary care md and did more tests with mercury thermometer.Based on above problem, we have emailed and phoned (b)(6) at the first time.In the email, we talked about recall the unit of her to do further research, investigate if the product failures and what happened.Meanwhile, we briefly illustrate to (b)(6) about how to use infrared thermometer correctly and introduce characteristics of fever alert of our product pc828, we suppose that 2 situations may exist: 1.Product malfunction; 2.Using method are not correct.We are expecting that (b)(6) can cooperate us to double check the pc828 according to correct using method and in a suitable environment requirement, but (b)(6) insist on product malfunction.So we have informed (b)(6) to send back the product freely for investigation and she agreed, we will send her a new one.Currently we are waiting for (b)(6) next action.(b)(6) 03/25/2021.

Event Description

The initial report descriptions as below: we received a notification letter of patient complaint and forwarded by mdr team of fda on feb.25, 2021.The report number is mw5099251, we saw that the patient (b)(6) declared she got much anxiety and did much unnecessary treatment and testing during using our product- infrared thermometer pc828.As her description, when she just recovered from a non-covid flu symptoms, pc828 still continual gave her inconsistent and incorrect temperature readings about 3 weeks, which caused her to consult a primary care md and conduct more tests with mercury thermometer.Based on the above problem, we have emailed and phoned (b)(6) for the first time.In the email, we talked about the recall unit for her to do further research, investigate if the product failures and what happened.Meanwhile, we briefly illustrated to (b)(6) about how to use infrared thermometer correctly and introduce characteristics of fever alert of our product pc828, we suppose that 2 situations may exist: product malfunction or the using method is not correct.We are expecting that (b)(6) can cooperate with us to countercheck the pc828 according to the correct using method and in a suitable environment requirement, but (b)(6) insisted on product malfunction.So we have informed (b)(6) to send back the product freely for investigation and she agreed.We will send her a new one.Currently, we are waiting for (b)(6) next action.(b)(6).(b)(6) 2021.The new updated information: after email communication, the patient (b)(6) told that her pc828 infrared thermometer is sometimes (not always) did not report her temperature correctly.It is not necessary for her to have a replacement thermometer.So, we think the patient has mastered the requirements and methods for the correct use of our infrared thermometer.(b)(6).(b)(6) 2021.

Manufacturer Narrative

After email communication, the patient (b)(6) told that the pc828 infrered thermometer sometimes (not always) did not report her temperature correctly during using, but it is not necessary for her to have a replacement.So, we think she has mastered the requirements and methods for the correct use of our infrared thermometer.(b)(6).(b)(6) 2021.

• Brand Name: FLTR
• Type of Device: INFRARED THERMOMETER
• Manufacturer (Section D): SHENZHEN PACOM MEDICAL INSTRUMENTS CO., LTD.; no. 5,gongye 5th rd.,jiangbian; songgang st., bao'an dist.,; shenzhen, guangdong 51810 5; CH 518105
• MDR Report Key: 11586900
• MDR Text Key: 243926845
• Report Number: 3013147512-2021-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• PMA/PMN Number: K172889
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 02/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: PC828
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: MW5099251
• Patient Sequence Number: 1
• Patient Outcome(s): Other