MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOTICS, INC ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2); ENHANCED ESTRADIOL IMMUNOASSAY

Model Number	N/A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cause for the discordant enhanced estradiol (ee2) results is unknown.Siemens healthcare diagnostics is investigating.The interpretation of results section of the instructions for use states: "results of this assay should always be interpreted in conjunction with patient's medical history, clinical presentation and other findings." mdr 1219913-2018-00233, mdr 1219913-2018-00234, and mdr 1219913-2018-00235 were filed for additional sample testing for the same patient.
Event or Problem Description
Customer observed elevated advia centaur xp enhanced estradiol results for three samples from the same patient compared to clinical expectations and an alternate method.There are no reports that treatment was altered or prescribed or adverse health consequences due to the elevated advia centaur xp enhanced estradiol results.
Additional Manufacturer Narrative
Mdr was filed on september 13, 2018 reporting elevated advia centaur enhanced estradiol results for three samples from the same patient compared to clinical expectations and an alternate method.December 6, 2018 - additional information: the customer returned two patient samples that were processed n = 1 neat and 1:2, 1:4 and 1:8 on advia centaur xp, and at n = 2 on immulite 2000 xpi and dimension vista.The patient sid (b)(6) was pretreated with hbt and tested on the advia centaur ee2 assay.Sample 1 - sid (b)(6): customer lab; advia centaur xp ee2 result = 424.23 pmol/l.Customer lab sent out for alternate method = 63 pmol/l.Siemens advia centaur xp ee2 data.Neat= 408.25 pmol/l.Hbt= 152.97 pmol/l.1:2 dilution= 200.9 pmol/l.1:4 dilution= 139.17 pmol/l.1:8 dilution = 59.38 pmol/l.Siemens immulite 2000 xpi e2 data =87.7 pmol/l.Siemens vista e2 data= 71.9 pmol/l.Sample 2 - sid (b)(6): customer lab advia centaur xp ee2 result = 427.61pmol/l.Customer lab sent out for alternate method = 97pmol/l.Siemens advia centaur xp ee2 data-.Neat= 380.1 pmol/l.1:2 dilution= 206.8 pmol/l.1:4 dilution= 124.4 pmol/l.1:8 dilution = 65 pmol/l.Siemens immulite 2000 xpi e2 data= 169 pmol/l.Siemens dimension vista e2 data= 87.7 pmol/l.This issue only affected sample from this patient.No information is known about medication taken by the patient.Results obtained from advia centaur xp recovered high compared to immulite 2000 xpi and dimension vista, which recovered much lower.The serially diluted patient samples showed a linear decrease indicating a sample specific interference.Pretreatment with heterophilic blocking tubes decreased the ee2 result for patient sid (b)(6) by over 50%, indicating a heterophilic interference.The limitations section of the instructions for use states: "heterophilic antibodies in human serum can react with reagent immunoglobulins, interfering with in vitro immunoassays.(6) patients routinely exposed to animals or animal serum products can be prone to this interference and anomalous values may be observed.Additional information may be required for diagnosis." a siemens product non-conformance has not been identified.No further action is required.Mdr 1219913-2018-00233 supplemental 1, mdr 1219913-2018-00234 supplemental 1, and mdr 1219913-2018-00235 supplemental 1 were filed for additional sample testing for the same patient.

• Brand Name: ADVIA CENTAUR XP ENHANCED ESTRADIOL (EE2)
• Common Device Name: ENHANCED ESTRADIOL IMMUNOASSAY
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOTICS, INC; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 7872338
• Report Number: 1219913-2018-00232
• Device Sequence Number: 11354287
• Product Code: CHP
• UDI-Device Identifier: 00630414574646
• UDI-Public: 00630414574646
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/20/2019
• Device Model Number: N/A
• Device Catalogue Number: 10491445
• Device Lot Number: 22758046
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/21/2018
• Supplement Date Received by Manufacturer: 12/06/2018
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 12/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 34 YR