FDA.reportPublic FDA data

MAUDE MDR 6313897

MDR report key
6313897
Report number
1823260-2017-00253
Event key
0
Event type
3
Date of event
2016-07-26
Date received
2017-02-09
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
100
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
1CMV IGG, IGG ANTIBODIES TO CYTOMEGALOVIRUSENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSROCHE DIAGNOSTICSLFZNA04784596190174473R Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-02-090

Event Narratives#

N

Patient 1

THIS EVENT OCCURRED IN (B)(6). (B)(4). MEDWATCH EXPIRATION DATE - THE EXPIRATION DATE WAS PROVIDED AS SEPTEMBER 2017.

D

Patient 1

THE CUSTOMER STATED THAT THEY RECEIVED AN ERRONEOUS RESULT FOR ONE PATIENT SAMPLE TESTED FOR THE ELECSYS CMV IGG ASSAY (CMVIGG) ON A COBAS 6000 E 601 MODULE (E601). THE ERRONEOUS RESULT WAS REPORTED OUTSIDE OF THE LABORATORY. THE CUSTOMER COMPLAINS ABOUT THE POOR SPECIFICITY OF THE CMVIGG REAGENT. WITH THE DIASORIN CMV IGG AND BIORAD CMV IGM TESTING METHODS, A SEROCONVERSION IS SUSPECTED IN THE PATIENT. WITH THE ROCHE CMVIGG METHOD, THE SEROCONVERSION IS NOT CLEAR. THE IGM RATE INCREASES, BUT THE IGG RATE IS STABLE FROM (B)(6) 2016 TO (B)(6) 2017. THE FIRST SAMPLE FROM THE PATIENT, DATED (B)(6) 2016, RESULTED AS (B)(6) FOR THE ELECSYS CMV IGM IMMUNOASSAY ((B)(6)) WHEN TESTED ON THE CUSTOMER'S E601 ANALYZER. THIS SAMPLE WAS REPEATED ON THE E601 ANALYZER ON (B)(6) 2017, RESULTING AS (B)(6). WHEN THE SAMPLE WAS TESTED WITH THE DIASORIN CMV IGG METHOD, THE RESULT WAS (B)(6) AND WHEN TESTED WITH THE BIORAD CMV IGM METHOD, THE RESULT WAS (B)(6) A SECOND SAMPLE FROM THE PATIENT, DATED (B)(6) 2016, RESULTED AS (B)(6) WHEN TESTED ON THE E601 ANALYZER. THIS SAMPLE WAS REPEATED ON THE E601 ANALYZER ON (B)(6) 2017, RESULTING AS (B)(6). A THIRD SAMPLE FROM THE PATIENT, DATED (B)(6) 2016, RESULTED AS (B)(6) WHEN TESTED ON THE E601 ANALYZER. WHEN THE SAMPLE WAS TESTED WITH THE DIASORIN CMV IGG METHOD, THE RESULT WAS (B)(6) AND WHEN TESTED WITH THE BIORAD CMV IGM METHOD, THE RESULT WAS (B)(6). THE SAMPLE WAS ALSO REPEATED WITH THE DIASORIN CMV IGG METHOD,(B)(6). A FOURTH SAMPLE FROM THE PATIENT, DATED (B)(6) 2017, RESULTED AS (B)(6) WHEN TESTED ON THE E601 ANALYZER. A FIFTH SAMPLE FROM THE PATIENT, DATED (B)(6) 2017, RESULTED AS (B)(6) WHEN TESTED ON THE E601 ANALYZER. WHEN THE SAMPLE WAS TESTED WITH THE DIASORIN CMV IGG METHOD, THE RESULT WAS (B)(6) AND WHEN TESTED WITH THE BIORAD CMV IGM METHOD, THE RESULT WAS (B)(6). WHEN THIS SAMPLE WAS TESTED WITH THE BIOMERIEUX ANTI-CMV IGG AVIDITY METHOD, THE AVIDITY WAS FOUND TO BE (B)(6). THE PATIENT WAS NOT ADVERSELY AFFECTED. THE SERIAL NUMBER OF THE USED E601 ANALYZER WAS REQUESTED, BUT NOT PROVIDED. CALIBRATION AND QUALITY CONTROLS WERE WITHIN EXPECTED RANGES.

N

Patient 1

THREE SAMPLES FROM THE PATIENT WERE PROVIDED FOR INVESTIGATION. ONE SAMPLE WAS DATED (B)(6) 2016 AND THE OTHER TWO SAMPLES WERE DATED AS (B)(6) 2017. UPON INVESTIGATION, THE SAMPLE FROM (B)(6) 2016 WAS DETERMINED TO BE NON-REACTIVE FOR THE ROCHE CMVIGM ASSAY AND REACTIVE FOR THE ROCHE CMVIGG ASSAY. THE SAMPLES FROM (B)(6) 2017 WERE DETERMINED TO BE REACTIVE FOR THE ROCHE CMVIGM ASSAY AND REACTIVE FOR THE ROCHE CMVIGG ASSAY. THE RESULTS OBTAINED BY THE CUSTOMER WERE DUPLICATED. THE (B)(6) 2016 SAMPLE WAS DETERMINED TO BE NEGATIVE USING BOTH THE RECOMLINE CMV IGM ASSAY AND CMV IGG ASSAY. THE DISCREPANCY OBSERVED WITH THE ROCHE CMVIGG ASSAY RESULT IS IN LINE WITH THOSE OF OTHER COMPETITOR RESULTS OBTAINED BY THE CUSTOMER FOR EARLY SAMPLES OF THIS PATIENT.THE (B)(6) 2017 SAMPLES WERE FOUND TO BE REACTIVE WITH BOTH RECOMLINE CMV IGM AND CMV IGG ASSAYS. THE OBTAINED REACTIVITY PATTERN SUGGESTS AN EARLY PHASE INFECTION. ALL SAMPLES FROM THIS PATIENT SHOWED REACTIVE RESULTS WITH THE ROCHE CMVIGG ASSAY INDEPENDENT OF THE SAMPLING DATE. A CMV IGM SEROCONVERSION WAS CONCORDANTLY DETERMINED WITH THE FIRST IGM REACTIVE SAMPLE FROM (B)(6) 2017 IN BOTH THE ELECSYS CMV IGM ASSAY AND THE RECOMLINE CMV IGM ASSAY. FURTHER ANALYSES REVEALED THAT THE SAMPLES OF THIS PATIENT SHOWED DOMINANT REACTIVITY TO ONLY ONE OUT OF FIVE SUBMODULES OF THE ELECSYS CMV IGG ASSAY. THIS PATTERN IS RARE FOR A RECENT OR PERSISTING INFECTION WITH CMV ESPECIALLY WHEN OBSERVED OVER A LONGER PERIOD OF TIME. IN CONTRAST, SUCH A PATTERN CAN BE ASSOCIATED WITH SUBMODULE SPECIFIC INTERFERENCE. TAKING THESE DATA TOGETHER, A FALSE-POSITIVE RESULT FOR THIS PATIENT IN THE ROCHE CMVIGG ASSAY CANNOT BE RULED OUT. THE OBSERVED SEROCONVERSION FOR CMV IGM TOGETHER WITH THE LOW AVIDITY OF CMV SPECIFIC IGG ANTIBODIES AS DETERMINED BY THE CUSTOMER CAN BE INDICATIVE OF A PRIMARY INFECTION WITH CMV. AS CLAIMED IN PRODUCT LABELING, SINGLE FALSE POSITIVES CAN OCCUR. THE REAGENT WAS DETERMINED TO BE PERFORMING WITHIN SPECIFICATION.