MAUDE Adverse Event Report: SIEMENS HEALTHCARE DIAGNOSTICS INC. ATELLICA CH CALCIUM_2 (CA_2)

Model Number ATELLICA CH CALCIUM_2 (CA_2)

Device Problem High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The customer contacted a siemens customer care center (ccc).On (b)(6) 2021, a siemens customer service engineer (cse) was dispatched to the customer site to troubleshoot a reagent probe issue on the atellica ch 930 analyzer, which upon evaluation did not indicate to be related to the discordant calcium_2 results.Quality controls (qc) had recovered out of range on (b)(6) 2021.Qc recovered in range after recalibrating the calcium_2 assay on (b)(6) 2021 and subsequently replacing the calcium_2 reagent pack on (b)(6) 2021.Siemens is investigating the issue.

Event Description

Discordant, falsely elevated calcium_2 (ca_2) results were obtained on 16 patient samples on an atellica ch 930 analyzer using atellica ch calcium_2 (ca_2) reagent.The discordant results were reported to the physician(s), who questioned the results.The samples were repeated for ca_2 on the same instrument after recalibrating the assay, recovering lower.The repeat results were reported, as the correct results, to the physician(s).There are no known reports of patient intervention or adverse health consequences due to the discordant, falsely elevated calcium_2 (ca_2) results.

Manufacturer Narrative

Siemens filed the initial mdr 2432235-2021-00146 on 14-jun-2021.Additional information (23-jun-2021): a review of the customer's calcium_2 (ca_2) quality controls (qc) shows evidence of imprecision and out of range recovery.Although discrepant ca_2 results were obtained using the same reagent pack and well, there were also ca_2 results obtained using the same reagent pack and well with no recovery issues, indicating the issue is not due to a reagent nonconformance.Siemens reviewed the ca_2 calibration data from the time of the event and observed significant variation in the calibration coefficients using ca_2 reagent lot 201251 and chem cal lot 228150.The variability observed with the calibration coefficient can impact ca_2 qc and patient result recovery.A review of the service history for the atellica ch 930 analyzer (serial number: (b)(6)) showed multiple service visits to investigate errors related to the reagent 1 (r1) probe.Prior to the customer obtaining discrepant results, the customer service engineer (cse) replaced the r1 probe and the level sense for the r1 probe.The cse also performed probe alignments.However, the r1 errors persisted and the cse returned and replaced both reagent arms, the r1 drain, and the reaction washer tubing, after which no further issues occurred.Siemens cannot rule out instrument related causes or issues related to calibrator reconstitution/handling as contributing factors to the event.The cause of the event is unknown.The reagent is performing according to specifications.No further evaluation of this device is required.

• Brand Name: ATELLICA CH CALCIUM_2 (CA_2)
• Type of Device: ATELLICA CH CALCIUM_2 (CA_2)
• Manufacturer (Section D): SIEMENS HEALTHCARE DIAGNOSTICS INC.; 511 benedict ave; tarrytown NY 10591
• MDR Report Key: 11991743
• MDR Text Key: 280889818
• Report Number: 2432235-2021-00146
• Device Sequence Number: 1
• Product Code: CJY
• UDI-Device Identifier: 00630414220697
• UDI-Public: 00630414220697
• Combination Product (y/n): N
• PMA/PMN Number: K083386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: ATELLICA CH CALCIUM_2 (CA_2)
• Device Catalogue Number: 11097644
• Device Lot Number: 201251
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/23/2021
• Supplement Dates FDA Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1