MAUDE Adverse Event Report: DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L GENERAL PURPOSE PROBE, 400 SERIES; THERMOMETER, ELECTRONIC, CLINICAL

Model Number M1024231

Device Problems Incorrect Measurement (1383); Incorrect, Inadequate or Imprecise Result or Readings (1535); Output Problem (3005)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The defective sample was not returned for further inspection, and no issues were found during the review of internal documentation.Therefore, a root cause cannot be established.Due to the root cause determination, a corrective action has not been taken.An internal complaint (b)(4) was received indicating that a general purpose probe (part m1024231, lot 45601408) failed during use.The end user reported that the temperature readings had significant variances that were resolved by changing the probe.The defective sample was not returned for evaluation.Therefore, a functional inspection of the device could not be performed.The work order for the reported lot was reviewed and no issues were reported during the inspection of the product.Functional results of the sub-assembly work orders assigned to the finished good lot were reviewed, and it was confirmed that, during the functional sampling of the material, all results were found to be within tolerance.The previous two years of internal complaints were reviewed.Similar reports for the same part number could not be identified.Product in process for the sub-assembly was reviewed.At the time of the investigation, 40 units were functionally tested and all results were found to be within tolerance.Inspection of the product is based on an aql of 0.65 percent, level 1.An inventory check at the manufacturing plant also was performed and five lots of the affected sub-assembly were identified.No rejects were generated during the functional inspection of the product.An inventory check was requested at the distribution facility.However, there was no product in storage for the reported finished good number.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A general purpose probe was placed in the patient's rectum and significant variations were noted in temperature.The temperature increased from 18c to 36c.The issue was resolved by changing the probe.

• Brand Name: GENERAL PURPOSE PROBE, 400 SERIES
• 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
• Manufacturer (Section G): DEROYAL CIENTIFICA DE LATINOAMERICA S.R.L; global park; box 180-3006, 602 parkway; la aurora, heredia, heredia 146 ; CS 146
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 8373684
• MDR Text Key: 141342031
• Report Number: 9613793-2019-00001
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K925791
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M1024231
• Device Lot Number: 45601408
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1