FDA.reportPublic FDA data

MAUDE MDR 6280310

MDR report key
6280310
Report number
1823260-2017-00157
Event key
0
Event type
3
Date of event
2017-01-02
Date received
2017-01-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
NA MICHAEL LESLIE
Address
9115 HAGUE ROAD NA INDIANAPOLIS IN 46250 US
Phone
317-317-3175
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1FOLATE IIIACID, FOLIC, RADIOIMMUNOASSAYROCHE DIAGNOSTICSCGNNA07559992190ASKUR Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-01-260

Event Narratives#

N

Patient 1

(B)(4). THIS EVENT OCCURRED IN (B)(6).

D

Patient 1

THE CUSTOMER RECEIVED QUESTIONABLE RESULTS FOR ELECSYS FT4 II ASSAY, ELECSYS VITAMIN B12 IMMUNOASSAY, ELECSYS FOLATE III ASSAY, ELECSYS BRAHMS PCT, AND ELECSYS TSH ASSAY FOR ONE PATIENT AND SUSPECTED AN INTERFERENCE WITH BIOTIN FROM THE QIZENDAY TREATMENT THE PATIENT WAS RECEIVING. THE CUSTOMER USED A COBAS 6000 E 601 MODULE. THE SERIAL NUMBER WAS REQUESTED BUT WAS NOT PROVIDED. SPECIFIC DATA AND ADDITIONAL INFORMATION FOR THE COMPLAINT WAS REQUESTED BUT WAS NOT PROVIDED. INFORMATION CONCERNING IF ANY ERRONEOUS RESULT WAS REPORTED OUTSIDE THE LABORATORY WAS REQUESTED BUT IT WAS UNKNOWN. THE PATIENT WAS NOT ADVERSELY AFFECTED. THE COMPLAINT ALSO INVOLVED ELECSYS FT4 II ASSAY, ELECSYS VITAMIN B12 IMMUNOASSAY, ELECSYS BRAHMS PCT, AND ELECSYS TSH ASSAY. REFER TO THE MEDWATCHS WITH PATIENT IDENTIFIERS (B)(6) FOR THE OTHER ASSAYS INVOLVED.

N

Patient 1

ADDITIONAL INFORMATION WAS RECEIVED FOR THE COMPLAINT. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA.

N

Patient 1

THE UNITS OF MEASURE FOR THE ASSAYS INVOLVED IN THIS EVENT WERE PROVIDED AS FOLLOWS: FT4: PMOL / L. B12: PG / ML. FOL: NMOL / L. PCT: NG / ML. TSH: MU / L. SAMPLES DRAWN FROM THE PATIENT ON (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, (B)(6) 2017, AND (B)(6) 2017 WERE SUBMITTED FOR INVESTIGATION. THE SAMPLES WERE TESTED ON A COBAS E601 ANALYZER AND A COBAS E411 ANALYZER. BASED ON THE RESULTS FOR FOUR OF THE SAMPLES, AN IMMUNOGLOBULIN THAT REACTS WITH THE REAGENT AND AFFECTS THE RESULTS WAS SUSPECTED. NO INTERFERING FACTOR TO STREPTAVIDIN WAS FOUND IN THE SAMPLES.

N

Patient 1

THE BIOTIN CONCENTRATION WAS MEASURED IN THE SAMPLES PROVIDED: (B)(4). FOR ALL OF THE SAMPLES DRAWN WHEN THE PATENT WAS KNOWN TO BE TAKING THE QIZENDAY TREATMENT, THE RESULT WAS HIGHER THAN THE ALLOWABLE CONCENTRATIONS SPECIFIED IN THE METHOD SHEETS OF ALL INVOLVED ASSAYS. THE RESULT FOR THE SAMPLE FROM (B)(4) 2017 WHEN THE PATIENT MAY HAVE NOT BEEN TAKING THE QIZENDAY TREATMENT WAS NOT ABOVE THE ALLOWABLE CONCENTRATIONS. THE HIGH BIOTIN CONCENTRATION MOST LIKELY CAUSED THE ISSUE. INTERFERENCE WITH ASSAYS THAT USE THE BIOTIN-STREPTAVIDIN TECHNOLOGY IS POSSIBLE AND THE THERAPY SHOULD BE STOPPED FOR ONE WEEK BEFORE MEASUREMENTS ARE DONE.