MAUDE Adverse Event Report: WALGREENS PULSE OXIMETER

Lot Number 02215062

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

Patient Problem Insufficient Information (4580)

Event Date 03/05/2022

Event Type  malfunction  

Event Description

Pulse oximeter inaccurate; i was checking my o2 levels with a (b)(6) otc pulse oximeter, non-prescription, and the levels fluctuate between 96 and 99.Even dipping so low as 92 when my skin isn't blue or anything and still natural, normal color.Is it not a very reliable pulse oximeter? fda safety report id# (b)(4).

Event Description

Additional information received for report mw5107960 on: 04/01/2022.

• Brand Name: WALGREENS PULSE OXIMETER
• Type of Device: OXIMETER
• MDR Report Key: 13711043
• MDR Text Key: 287029862
• Report Number: MW5107960
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 02215062
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: HYDROXYZINE; IMMUNE SUPPORT; IRON; SERTRALINE
• Patient Outcome(s): Other
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White