MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L ADULT SKIN TEMPERATURE PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number V81-010400

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/02/2020

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (b)(4) was received indicating that an adult skin probe (part v81-010400, lot 52112354) malfunctioned during use.Specifically, the device only read up to 92 degrees fahrenheit.The investigation is ongoing at this time.When new and critical information is available, this report will be updated.

Event Description

A temperature probe was used on a patient.The probe was only reading up to 92 degrees.The probe was connected via an interface cable to a phillips monitor.

Event Description

A temperature probe was used on a patient.The probe was only reading up to 92 degrees.The probe was connected via an interface cable to a phillips monitor.

Manufacturer Narrative

Root cause: the root cause is undetermined.The returned sample functioned properly.No issues were identified with the sample or in the documentation review.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint ((b)(4)) was received indicating that an adult skin probe (part v81-010400, lot 52112354) malfunctioned during use.Specifically, the device only read up to 92 degrees fahrenheit.The customer returned five probes for evaluation.These were tested and found to be within specification.The device history record was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Functional testing performed on the reported lot during manufacturing was within specification.Product in process was functionally inspected and no issues were found.Complaints for the last two years were reviewed, and no similar issues have been reported.The investigation is complete at this time.If new and critical information is available, this report will be updated.

• Brand Name: ADULT SKIN TEMPERATURE PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• MDR Report Key: 10765577
• MDR Text Key: 214614175
• Report Number: 9613793-2020-00002
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 50749756778218
• UDI-Public: 50749756778218
• Combination Product (y/n): N
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: V81-010400
• Device Lot Number: 52112354
• Date Manufacturer Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1