inforMED
InjuryFLK

NOT KNOWN

Received Jul 30, 2008 · Event occurred Jul 22, 2008

Report MW5007822 · MDR key 1084305

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Product code (FLK)
Model (763ORAL)

Device

Generic name

Thermometer

Manufacturer

Not Known

Model number

763ORAL

Catalog number

763ORAL

Lot number

12251107

Product problems

  • False Reading From Device Non-Compliance

Patient

Not reported

  • Therapy/non-surgical treatment, additional
  • Hospitalization required

Narrative

Description of Event or Problem

BABE ADMITTED TO NICU. CBC AND CRP OBTAINED AND RETURNED WNL. NO FEVER ON ADMISSION. DR. ARRIVED AT 1600 TO DO LP. BEGAN TO QUESTION THE VALIDITY OF THE TEMP TAKEN AT HOME. DAD ARRIVES WITH HOME THERMOMETER, AND TEMP TAKEN WITH THAT IS 101.7. IMMEDIATELY TOOK TEMP WITH OUR THERMOMETER AND THAT WAS 98. LP CANCELLED. DID NOT START ANTIBIOTICS AND KEPT CHILD OVER NIGHT AND ALL TEMPS WNL. DISCHARGED TO HOME NEXT MORNING. CLINICAL ENGINEERING VERIFIES THE ACCURACY OF HOSP OWNED THERMOMETERS. THERMOMETER IS A DIGITAL THERMOMETER THAT COMES IN A PREPACKAGED PACK THAT IS GIVEN TO PARENTS AND BABIES AT THE TIME OF BABY'S BIRTH. DIGITAL THERMOMETERS ARE NOT CHECKED IN THE HOSP PRIOR TO BEING GIVEN TO THE PARENTS. FACILITY DOES TELL MFR OF THE COMPLETE PACK TO INCLUDE A THERMOMETER. MFR PICKS THE THERMOMETER TO BE PLACED IN THE PACK. SEE SCANNED PAGES.

Description of Event or Problem

AN INFANT ADMITTED TO NICU FOR SEPSIS WORKUP, REPORTEDLY HAD A RECTAL TEMP OF 103. RECTALLY AT HOME USING THE THERMOMETER RECEIVED FOR HOME USE AS A NEWBORN, AT THE KEARNEY CLINIC BABY DID NOT HAVE A FEVER, BUT PROCEEDED WITH A BLOOD AND URINALYSIS. NO HARM TO PT.