MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS, INC. ATELLICA IM TOTAL HCG (THCG)

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	12/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The quality control (qc) that was run before (at 11:53) gave results higher than the range for level 2.The level 2 qc was repeated and gave the result of 24.Quality control results (miu/ml): level 1 (k40981) result: 6.4; level 2 (k40982) result: 40; level 3 (k40983) result: 410.2.Per siemens specifications: level 1 qc range: 3.51 - 11.1; level 2 qc range: 19.1 - 31.1; level 3 qc range: 153 - 225.On 12/16/2019, the system was checked by the siemens customer service engineer (cse).The cse replaced the reagent probes and realigned.Siemens healthcare diagnostics is investigating the cause of the discordant atellica im thcg results.The ifu states in the interpretation of results section: "results of this assay should always be interpreted in conjunction with the patient's medical history, clinical presentation, and other findings." the ifu states in the limitations section: "all in vitro assays can generate erroneous results, both clinically false positive results (test results suggesting a condition that is absent) and clinically false negative results (test results failing to identify a condition that is present)." mdr 1219913-2019-00282 (repeat testing) was filed for the same event.
Event or Problem Description
Discordant high atellica im total hcg (thcg) results were obtained for a patient when compared to another atellica im instrument.Patient treatment was not prescribed or altered.There was no report of adverse health consequences due to the discordant total hcg result.
Additional Manufacturer Narrative
Siemens filed the initial mdr 1219913-2019-00281 on december 27, 2019.April 09, 2020 additional information: the sid (b)(4) was run for thcg and result of 65.6 was generated.Two of the three levels of quality control (qc) were out of range that day.The qc results were as follows: result units: miu/ml level 1 (k40981) result: 6.4 (3.51 - 11.1) level 2 (k40982) result: 40 (19.1 - 31.1) level 3 (k40983) result: 410.2 (153 - 225) the patient sample was repeated on another instrument and a result of 4.8 was generated and considered to be the correct result.The qc level 2 control was also repeated and a result of 24 was generated which is within the range.Review of the ic debug logs showed that the patient sample ran without error.Per the service report, the reagent probes were replaced and realigned.Based on the information given the incorrect result was due to an increase in rlu therefore we would not expect to see any issues with the aspiration traces and replacing and realigning the reagent probes would not correct this issue.There was no definitive root cause found as a result of the investigation.Follow up with the local team indicated that the instrument is operational, and the customer is reporting thcg results.The instrument is performing within specifications.No further evaluation of the device is required.Mdr 1219913-2019-00282 supplemental report 1 was filed for the same event.

• Brand Name: ATELLICA IM TOTAL HCG (THCG)
• Common Device Name: TOTAL HCG
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS, INC.; 511 benedict avenue; tarrytown NY 10591 5097
• MDR Report Key: 9526217
• Report Number: 1219913-2019-00281
• Device Sequence Number: 366383
• Product Code: JHI
• UDI-Device Identifier: 00630414600031
• UDI-Public: 00630414600031
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K172322
• 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): 04/13/2020

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: 06/14/2020
• Device Model Number: N/A
• Device Catalogue Number: 10995690
• Device Lot Number: 27477313
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 12/27/2019
• Supplement Report FDA Received Date: 04/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR