MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ADVIA CENTAUR CP TOTAL HCG ASSAY; TOTAL HCG 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	02/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer contacted the siemens customer care center (ccc) to report discordant, falsely elevated advia centaur cp total human chorionic gonadotropin (hcg) result on a patient sample.The system event log has no errors at the time of the incident and quality control results were within acceptable range on (b)(6) 2020.A five patient repeatability check was performed.Patient repeatability check (n=5) results: sample 1 mean= 89.1 cv= 2.4, sample 2 mean= 1.496 cv= 9.65, sample 3 mean= 0.88 cv= 10.63, sample 4 mean= 0.872 cv= 9.22, sample 5 mean= 146.02 cv= 1.75.Siemens healthcare diagnostics is investigating.
Event or Problem Description
A falsely elevated advia centaur cp total human chorionic gonadotropin (hcg) result was obtained by the customer on a patient sample and considered discordant compared to a negative hcg result run at another hospital.The negative alternate hospital hcg result was reported to the physician(s) as the corrected result.There are no known reports that treatment was altered or prescribed or adverse health consequences due to the discordant advia centaur cp total human chorionic gonadotropin (hcg) result.
Additional Manufacturer Narrative
Mdr 1219913-2020-00089 was filed on 12-mar-2020 for a falsely elevated advia centaur cp total human chorionic gonadotropin (hcg) patient result.Mdr 1219913-2020-00089 supplemental report 1 was filed on 07-apr-2020 for additional information.17-apr-2020 - additional information: siemens has been provided the advia centaur cp hcg reagent lot number.The physician(s) had questioned the elevated advia centaur cp total human chorionic gonadotropin (hcg) patient result and reported the patient was not pregnant.A siemens field application specialist checked and found the dark count, pipetting, sample probe, reagent probe and customer performed maintenance to be acceptable.D4.Lot # 309; expiration date 31-mar-2020.H4.Device manufacture date: 31-may-2019.23-apr-2020 - additional information: the information provided on 17-apr-2020 has been reviewed by siemens.The cause for the discordant high advia centaur cp hcg result is unknown.Contributing factors such as sample integrity and preanalytical variables cannot be ruled out.A potential product issue has not been identified.The customer is operational.The assay is performing within specification.No further evaluation of the device is required.
Additional Manufacturer Narrative
Mdr 1219913-2020-00089 was filed on 12-mar-2020 for a falsely elevated advia centaur cp total human chorionic gonadotropin (hcg) patient result.On 16-mar-2020 - additional information: siemens has reviewed the event data and has concluded the incident investigation.The initial sample is no longer available for further investigation.No other results were questioned by the customer from the time of this event.The system event log was reviewed, and no errors were identified.Quality control results were within range on 05-feb-2020.A total hcg repeatability precision check was performed since this event and found acceptable.The cause for the discordant high result is unknown, however contributing factors such as sample integrity and preanalytical variables cannot be ruled out.A potential product issue has not been identified.The customer has not raised any additional concerns since this event.The assay is performing within specification.No further evaluation of the device is required.

• Brand Name: ADVIA CENTAUR CP TOTAL HCG ASSAY
• Common Device Name: TOTAL HCG IMMUNOASSAY,
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown, ny
• MDR Report Key: 9824956
• Report Number: 1219913-2020-00089
• Device Sequence Number: 3069463
• Product Code: JHI
• UDI-Device Identifier: 00630414505152
• UDI-Public: 00630414505152
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K925277
• 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,Followup
• Report Date (Section B): 05/11/2020

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 10308984
• Device Lot Number: 309
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/16/2020; 04/17/2020
• Initial Report FDA Received Date: 03/12/2020
• Supplement Report FDA Received Date: 04/08/2020; 05/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1