FDA Adverse Event Injury Summary report: N

BREATHTEK (UBT)

MDR report key: 2118983 · Received April 28, 2011

Report

Report Number
3000718406-2011-00001
Event Type
Injury
Date Received
April 28, 2011
Date of Event
March 15, 2011
Report Date
October 20, 2017
Manufacturer
OTSUKA AMERICA PHARMACEUTICALS INC.
Product Code
MSQ
PMA / PMN Number
P100025
Adverse Event
Yes
Report Source
Manufacturer report
Reporter Location
IL, US
Reporter Occupation
HEALTH PROFESSIONAL
Health Professional
Yes

Narratives

Description of Event or Problem · 1

EVENT VERBATIM [LOWER LEVEL TERM]. ANAPHYLACTIC REACTION [ANAPHYLACTIC REACTION] CASE DESCRIPTION: A HEALTHCARE PROFESSIONAL REPORTED THAT A (B)(6) MALE PATIENT EXPERIENCED AN ANAPHYLACTIC REACTION. THE EVENT OCCURRED WHILE ON BREATHTEK (UBT) 13C-UREA. ON (B)(6) 2011, 30 MINUTES AFTER OFFICE STAFF ADMINISTERED THE BREATHTEK TEST, THE PT ATE SOME SHRIMP. ON (B)(6) 2011, TWO HOURS AFTER THE ADMINISTRATION OF THE BREATHTEK TEST AND ONE AND ONE-HALF HOURS AFTER EATING THE SHRIMP, THE PATIENT HAD AN ANAPHYLACTIC REACTION. THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM WHERE HE WAS ADMINISTERED AN UNKNOWN STEROID AND EPINEPHRINE. IT IS UNKNOWN IF ANY LABORATORY TESTS WERE PERFORMED. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDES NO KNOWN ALLERGIES. THE PATIENT'S CONCOMITANT MEDICATIONS AND PAST DRUG HISTORY ARE UNKNOWN. THE OUTCOME OF THE EVENT IS RECOVERED. FOLLOW-UP RECEIVED: TELEPHONE COMMUNICATION WITH DR (B)(6) INDICATED THAT THE PATIENT SAW AN ALLERGIST WHO STATED THAT HE HAD ANAPHYLACTOID REACTION, WHICH COULD HAVE BEEN CAUSED BY THE MANNITOL IN THE PRANACTIN CITRIC. HE WAS NEGATIVE INITIALLY FOR FOOD ALLERGIES, BUT HE WILL GO BACK FOR ANOTHER SKIN TEST FOR FOOD ALLERGIES IN THREE WEEKS TO RULE OUT A FALSE NEGATIVE. FOLLOW-UP RECEIVED: THE PATIENT STATED THAT HE CAME HOME AFTER THE BREATHTEK TEST AND CONSUMED SHRIMP. TWENTY MINUTES LATER, THE PATIENT NOTICED ITCHING IN HIS HANDS WITH RED PALMS WHICH PROGRESSED TO TINGLING AND NUMBNESS IN HIS LIPS. SOON AFTER HE NOTICED HIS FACE WAS SWOLLEN WITH HIVES ON HIS NECK. THE PATIENT'S VOICE BECAME HOARSE AND HE EXPERIENCED TROUBLE BREATHING AND FELT THAT HIS THROAT WAS CLOSING. THE PATIENT DROVE HIMSELF TO THE HOSPITAL AND WAS GIVEN INJECTIONS OF EPINEPHRINE, STEROIDS AND DIPHENHYDRAMINE. AFTER A COUPLE OF HOURS OF OBSERVATION, THE HIVES RESOLVED, BUT THE PATIENT WAS STILL SWOLLEN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND WAS TREATED WITH A MEDROL DOSE PACK, DIPHENHYDRAMINE, FAMOTIDINE A DUONEB NEBULIZER AND BISMUTH SUBSALICYLATE. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2011 WITH DIPHENHYDRAMINE AND EPINEPHRINE PENS IN CASE OF ANOTHER REACTION; HOWEVER, HE WAS STILL SWOLLEN. THE SWELLING RESOLVED ON (B)(6) 2011. THE PATIENT HAS NOT EXPERIENCED ANOTHER REACTION AND HAS HAD NO OTHER SYMPTOMS. ON (B)(6) 2011, HE SAW AN ALLERGIST WHO TESTED HIM FOR SHRIMP AND SESAME SEED FOOD ALLERGIES WHICH ALL CAME UP NEGATIVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 BREATHTEK (UBT) NONE MSQ

Patients

Seq Age Sex Outcome Treatment
1 45 YR Male Other| H CLARITHROMYCIN| LANSOPRAZOLE| PREVPAC| PREVPAC: AMOXICILLIN TRIHYDRATE| PREVPAC: AMOXICILLIN TRIHYDRATE| LANSOPRAZOLE| CLARITHROMYCIN