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

Model Number	V81-010400
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Low Readings (2460); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 9613793-2020-00002
• Device Sequence Number: 16428827
• Product Code: FLL
• UDI-Device Identifier: 50749756778218
• UDI-Public: 50749756778218
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K925791
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

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
• Operator of Device: Health Professional
• Device Model Number: V81-010400
• Device Lot Number: 52112354
• Initial Date Received by Manufacturer: 10/02/2020
• Supplement Date Received by Manufacturer: 10/02/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1