FDA Adverse Event Injury Summary report: N

BLOOD PLASMA FRACTIONATED PORPHYRINS

MDR report key: 9526179 · Received December 26, 2019

Report

Report Number
MW5091923
Event Type
Injury
Date Received
December 26, 2019
Date of Event
January 1, 2009
Report Date
December 16, 2019
Manufacturer
UNK
Product Code
JKJ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
OK, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY FAMILY HAS A HISTORY OF PORPHYRIA AIP MAINLY. MY MOTHER DIED OF PORPHYRIA. MY SON BEGAN HAVING SYMPTOMS AT THE AGE OF (B)(6) AFTER BEING AN OVERDOSE OF TWO DRUGS SIMULTANEOUSLY IW ATARAX AND VISTERAL. MY SON WAS GIVEN A BLOOD PLASMA FRACTIONATED PORPHYRIN TEST, THE TEST RESULTS WERE POSITIVE BUT THE PHD PERFORMING THE TEST SAID IT WAS NEGATIVE, IT WASN'T. IF I HAD SOME TEST STUDIES THAT WERE PERFORMED AND PARAMETERS, I COULD HAVE FOUGHT (B)(6). GO TO THEIR WEBSITE WHICH NOW STATES IT IS NOT AN FDA APPROVED TEST AND THERE ARE NO TEST STUDIES. PORPHYRINS, FRACTIONATED, PLASMA, TEST DETAIL, (B)(6) PORPHYRINS, FRACTIONATED, PLASMA TEST CODE 5519 CPT CODE(S) 82542 CPT CODE IS SUBJECT TO A (B)(6) LIMITED COVERAGE POLICY AND MAY REQUIRE A SIGNED ABN WHEN ORDERING. NOT OFFERED IN (B)(6). PLEASE PROVIDE SERVICE AREA INFO TO FIND AVAILABLE TESTS YOU CAN ORDER. TEST DETAILS INCLUDES UROPORPHYRIN, HEPTACARBOXYLPORPHYRIN, HEXACARBOXYPORPHYRIN, PENTACARBOXYPORPHYRIN, COPROPORPHYRIN, PROTO PORPHYRIN, TOTAL PORPHYRINS METHODOLOGY HIGH PERFORMANCE LIQUID CHROMATOGRAPHY (HPLC) ASSAY CATEGORY; THIS TEST WAS DEVELOPED AND ITS ANALYTICAL PERFORMANCE CHARACTERISTICS HAVE BEEN DETERMINED BY (B)(6). IT HAS NOT BEEN CLEARED OR APPROVED BY FDA. THIS ASSAY HAS BEEN VALIDATED PURSUANT TO THE CLIA REGULATIONS AND IS USED FOR CLINICAL PURPOSES. THIS TEST CODE IS FOR NON-(B)(6) PT TESTING. FOR (B)(6) PT TESTING, USE TEST CODE 10289. REF RANGE(S) UROPORPHYRIN? 0.2MCG/L, HEPTACARBOXYLPORPHYRIN? 0.2 MCG/L, HEXACARBOXYPORPHYRIN? 0.3 MCG/L, PENTACARBOXYPORPHYRIN? 0.4 MCG/L, COPROPORPHYRIN? 0.8 MCG/L, PROTOPORPHYRIN 0.4-4.8 MCG/L; TOTAL PORPHYRINS 1.0-5.6 MCG/L, LOINC CODES, PERFORMING LABORATORY; (B)(6). FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1313445 BLOOD PLASMA FRACTIONATED PORPHYRINS FLUOROMETRIC MEASUREMENTS, PORPHYRINS JKJ UNK
1313446 VISTARIL ---

Patients

Seq Age Sex Outcome Treatment
1 32 YR Disability