FDA.reportPublic FDA data

MAUDE MDR 6420522

MDR report key
6420522
Report number
1823260-2017-00600
Event key
0
Event type
3
Date of event
2017-03-01
Date received
2017-03-21
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
1IRON GEN.2PHOTOMETRIC METHOD, IRON (NON-HEME)ROCHE DIAGNOSTICSJIYNA0318369612217599301R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-210

Event Narratives#

N

Patient 1

FACILITY NAME CONTINUED - (B)(4). THIS EVENT OCCURRED IN (B)(6). (B)(4).

D

Patient 1

THE CUSTOMER IS QUESTIONING LOW RESULTS FOR 2 PATIENTS TESTED FOR IRON2 IRON GEN.2 (IRON2) ON A COBAS INTEGRA 800. THE CUSTOMER HAD REPORTED IRON2 RESULTS FOR 2 PATIENTS OUTSIDE OF THE LABORATORY WHERE THE RESULTS WERE QUESTIONED BY THE CLINICAL DOCTOR. SINCE THE CLINICAL DOCTOR QUESTIONED THE RESULTS, THE CUSTOMER DECIDED TO PERFORM A METHOD COMPARISON WITH 30 PATIENT SAMPLES BETWEEN THE INTEGRA 800 INSTRUMENT AND A HITACHI 7600 ANALYZER USING A WAKO REAGENT. BASED ON THE COMPARISON DATA PROVIDED, THE RESULTS FOR THESE 2 PATIENTS WERE ERRONEOUS. NO OTHER ERRONEOUS RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY. PATIENT 1 INITIAL IRON2 RESULT WAS 99 UG/DL ON THE INTEGRA 800. THE REPEAT RESULT FROM THE HITACHI 7600 ANALYZER USING WAKO REAGENT WAS 296 UG/DL. PATIENT 2 (FEMALE) INITIAL IRON2 RESULT WAS 120 UG/DL ON THE INTEGRA 800. THE REPEAT RESULT FROM THE HITACHI 7600 ANALYZER USING WAKO REAGENT WAS 442 UG/DL. THERE WAS NO ALLEGATION THAT AN ADVERSE EVENT OCCURRED. THESE PATIENTS WERE TAKING IRON SUPPLEMENTS SO THE CUSTOMER WAS AWARE THE IRON2 RESULTS COULD BE LOW DUE TO THIS. THE CUSTOMER IS WONDERING WHY THE WAKO REAGENT IS NOT AFFECTED THE SAME WAY. PRODUCT LABELING INDICATES THAT THE IRON2 TEST IS AFFECTED WHEN PATIENTS ARE TREATED WITH IRON SUPPLEMENTS OR METAL-BINDING DRUGS. IN THESE PATIENTS, THE DRUG-BOUND IRON MAY NOT PROPERLY REACT WITH THE REAGENT, WHICH CAN CAUSE LOW RESULTS. ROCHE CANNOT PROVIDE INFORMATION AS TO THE SPECIFICATIONS OR PERFORMANCE OF THE WAKO PRODUCT.

N

Patient 1

DURING TESTING, THE DIAGNOSTICALLY RELEVANT IRON BOUND TO TRANSFERRIN IS RELEASED DUE TO ACIDIC PH AND DETERGENT IN THE REACTION SOLUTION. IRON FROM OTHER SOURCES (HEMOGLOBIN, ENZYMES CONTAINING IRON-SULFUR CLUSTERS, ETC.) IS DIAGNOSTICALLY IRRELEVANT AND IS INTENTIONALLY NOT ASSESSED. THE DRUG IN THE SUPPLEMENTS CAN BIND IRON FROM THE SAMPLE. THIS PROCESS OCCURS IN THE PATIENT SAMPLE APART FROM THE ANALYZER, BUT IT LEADS TO LOWER IRON RESULTS BECAUSE THE IRON2 ASSAY DOES NOT DETECT THE DRUG BOUND IRON. A PRODUCT PROBLEM WAS NOT DETECTED. THE DEVICE OPERATES PER SPECIFICATION.